Venugopal Marar

(Solid tumors of Lung and Prostate

( Oncology/ Rare disease)
(RYBREVANT/ ERLEADA) Phase 3 PALOMA-3 study evaluating subcutaneous (SC) amivantamab combined with lazertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R mutations.
4/24/2024 – 09/05/2025

Strategic Leadership
• Provided strategic medical safety leadership across global programs, ensuring a robust
and compliant pharmacovigilance framework within J&J.
• Oversaw development and implementation of SOPs, safety processes, and governance
pathways supporting consistent safety oversight across clinical programs.
• Guided cross-functional alignment on safety strategy, ensuring integration of safety
priorities into clinical development and regulatory planning.

Safety Management & Risk Mitigation
• Led comprehensive safety management activities for multiple investigational and
marketed products, including development and execution of safety management and
risk-mitigation plans.
• Performed ongoing safety surveillance, medical review of safety data, and continuous
benefit-risk evaluations across global trials including ATLAs and PROTEUS/Erleada
programs.
• Identified emerging risks and recommended proactive mitigations aligned with
regulatory expectations and internal governance.
• Led development, review, and lifecycle maintenance of Risk Management Plans (RMPs)
for global submissions, ensuring alignment with EMA, MHRA, PMDA, and Health Canada
requirements.
• Authored and reviewed RMP safety specifications, pharmacovigilance plans, and risk-
minimization measures (RMMs), ensuring evidence-based mitigation aligned with
evolving safety profiles.
• Oversaw development and execution of REMS programs including ETASU,
prescriber/pharmacy training, communication tools, and controlled distribution
requirements.
• Monitored effectiveness of REMS and RMP strategies through quantitative/qualitative
assessments and CAPA implementation.
• Collaborated cross-functionally to ensure alignment of RMP and REMS strategies across
regulatory, clinical, labeling, and safety surveillance functions.

Signal Detection & Evaluation
• Directed signal detection activities, including medical evaluation of ICSRs, aggregate
trend analysis, and scientific literature review.
• Identified, validated, and characterized safety signals, supported signal assessments,
and contributed to internal Safety Governance Committee reviews.
• Developed evidence-based mitigation strategies and collaborated cross-functionally to
ensure timely communication of new safety information.

ICSR Review
• Medical review of cases
• Adherence to EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F)
• Strong understanding of ICH E2B(R3) standards for electronic ICSR transmission, including compliant submissions to FDA FAERS and EMA EudraVigilance, with experience resolving validation errors and managing follow-up submissions.
• Experienced with global safety and clinical data systems including Oracle Argus, ARISg, Empirica Signal, Evidas, and Medidata Rave and Spotfire supporting end-to-end pharmacovigilance operations, signal detection, and clinical safety data review.

Cross-Functional Collaboration
• Collaborated with Clinical Development, Regulatory Affairs, Biostatistics, Epidemiology,
and Medical Affairs to support benefit-risk analyses and safety decision-making.
• Partnered with medical monitors and operations teams to ensure alignment across SAE
management, signal processes, and risk-benefit discussions.
• Contributed safety perspectives to study protocols, statistical plans, IB updates,
investigator communications, and regulatory strategy. Collaborated well with the RWD team, exhibited understanding of the RWD/E lifecycle—data acquisition, curation, access, analysis, and evidence generation.

Vendor Oversight
• Provided medical and operational oversight of external safety vendors supporting case
processing, signal analytics, and aggregate report development.
• Ensured vendor compliance with J&J quality standards, regulatory timelines, data
accuracy, and audit/inspection readiness.
• Led coordination with external partners to optimize efficiency, accountability, and
quality of safety deliverables.

Regulatory Engagement
• Authored and reviewed safety-related components of regulatory submissions including
protocols, Investigator’s Brochures, DSURs, CTD modules, briefing books, and
regulatory responses.
• Supported regulatory interactions through preparation of safety summaries, signal
reports, and responses to global health authority inquiries.
• Ensured alignment of safety documentation with regulatory expectations and corporate
standards.

Aggregate and Expedited Reporting
• Expert knowledge of global pharmacovigilance regulations, including FDA requirements (21 CFR 312.32(CT), 314.80(PM), FAERS), EMA), ensuring compliant safety reporting and lifecycle risk management.
• Oversaw preparation, of aggregate safety reports including DSURs, PBRERs/PSURs, PADERs, (GVP Modules VI, VII, and IX, and ICH E2 guidelines (E2A–E2F) CCDS updates, and risk-management documentation.
• Provided medical oversight for expedited reporting (SAEs, SUSARs) ensuring global compliance with reporting timelines.
• Guided interpretation of aggregate safety data and integration of signal trends into core safety documents.

Leadership & Governance
• Chaired or supported internal Safety Review Committee meetings, providing expert
medical input on safety issues, emerging signals, and benefit-risk assessments.
• Supported safety governance by presenting safety insights to senior leadership and
aligning with strategic program priorities.
• Ensured audit and inspection readiness for FDA, EMA, ICH, GVP, CIOMS, across safety processes, including CAPA
development and continuous quality improvement.

Rangam Consultants
Bristol Myers Squibb (Princeton Pike, Lawrenceville, New Jersey)

Medical Monitor/senior Medical Director Safety Physician lead for Established brands (Contract)
Established products: Antivirals/Antibiotics.
01/03/2024 – 04/01/2024
• Medical monitoring of Phase 2 and Phase 3 clinical trials, ensuring protocol adherence, subject safety, and high-quality data integrity.
• Maintain deep working knowledge of the assigned treatment area including competitor landscape; generate and analyze insights and translate findings into strategic actions.
• Conduct comprehensive Medical-Legal-Regulatory (MLR) reviews to ensure scientific accuracy, balanced benefit–risk messaging, and compliance with FDA, EMA, MENA, and PMDA standards across HCP, payer, and patient materials.
• Experienced in advanced literature searching and evidence synthesis using Embase, PubMed/MEDLINE, Cochrane Library, and clinical trial registries to support medical monitoring, signal evaluation, and regulatory submissions.
• Drive clinical development strategy with medical input into trial design, protocols, Clinical Study Reports (CSRs), ISS/ISE, manuscripts, and white papers.
• Serve as medical expert partnering with BMS matrix teams, contributing to communication tools and programs that support optimal market access.
• Coordinate with cross-functional partners to communicate clinical trial results, evolving treatment guidelines, and other relevant data.
• Oversee safety reporting and ensure timely, compliant case processing.
• In collaboration with the study team and Development Lead, respond to IRB/EC/Health Authority queries.
• Respond to medical questions from study sites and staff regarding protocol conduct and patient safety during study start-up, enrollment, and ongoing subject management.
• Lead the core medical team in updating Company Core Data Sheets (CCDS) and ensuring medically sound labeling content.
• Participate in Safety Management Team (SMT) meetings to discuss emerging safety signals and propose appropriate actions.
• Review Informed Consent Forms (ICFs) for medical appropriateness and risk clarity.
• Author aggregate safety reports including DSURs, PSURs/PBRERs, and other regulatory documents.
• Provide cross-functional clinical development support, including contributions to the Investigator-Initiated Trial (IIT) program.
• Ensure diligent follow-up on all critical cases and Events of Special Interest (ESIs) aligned with Risk Management Plans (RMPs).
• Support the EU QPPV and other regional QPPVs on safety issues related to assigned products.
• Prepare medical write-ups for Adverse Outcomes of Special Interest (AOSE).
• Lead and execute labeling updates, ensuring accuracy and regulatory compliance.
• Directly responsible for case management activities for US FDA, EMA, and other global Health Authorities.
• Lead activities related to divestment, including updating medical sensitivity documents.
• Prepare timely and accurate responses to Health Authority inquiries.
• Conduct ongoing benefit–risk assessments for investigational and marketed products.
• Functional expertise in CARA, Veeva, and Veeva Verity safety/medical databases.

• Led the design and execution of global clinical development programs aligned with medical, scientific, regulatory, and commercial objectives across early- through late-phase development.
• Provided strategic medical leadership across the product lifecycle (Phase 1–3) for internally developed and partnered assets.
• Ensured proactive safety oversight in collaboration with Pharmacovigilance, including SAE review, medical monitoring, and compliance with global safety reporting requirements.
• Oversaw end-to-end clinical trial execution, partnering with Clinical Operations to enhance enrollment, ensure timeline adherence, and achieve on-time delivery of key milestones.
• Led cross-functional study teams, aligning medical strategy across Clinical Operations, Regulatory Affairs, Biometrics, and Safety to streamline processes and improve collaboration.
• Directed development and ensured scientific integrity of core clinical documents, including protocols, Investigator’s Brochures, CSRs, regulatory dossiers, and health authority response packages for compliance and clarity.
• Represented the clinical function in regulatory interactions with Health Authorities, ensuring adherence to GCP, pharmacovigilance regulations, SOPs, and global compliance standards.
• Bristol Myers Squibb (Princeton Pike, Lawrenceville, New Jersey)

• Provide strategic medical safety leadership across early development (FIH, dose escalation, PoC), clinical development, and post-marketing programs, ensuring compliance with ICH, GCP, FDA, EMA, and global pharmacovigilance regulations.
• Serve as product safety physician and medical monitor, overseeing clinical trial safety, SAE/ICSR review, signal evaluation, and spontaneous reporting for investigational and marketed products.
• Lead and maintain signal detection strategies and plans, performing continuous analysis of clinical and post-marketing safety data to identify emerging risks and trends, with emphasis on early-phase programs.
• Collaborated with early development and clinical teams to embed safety considerations into protocol design, first-in-human risk assessments, dose escalation strategies, and stopping rules, enhancing overall trial safety.
• Author, review, and maintain Company Core Safety Information (CCSI/CCDS) and safety sections of INDs, NDAs, MAAs, CSRs, and Investigator’s Brochures, ensuring accuracy and regulatory alignment.
• Led preparation and review of aggregate safety deliverables, including PSURs/PBRERs, DSURs, and safety summaries, supporting global submissions and facilitating regulatory approval processes.
• Developed and implemented risk management plans (RMPs) and REMS, identifying important risks and establishing risk minimization measures to ensure patient safety and regulatory compliance.
• Represent Clinical Safety & Pharmacovigilance at Labeling Committees, Safety Review Committees, and executive governance forums, providing clear medical risk–benefit assessments.
• Partner cross-functionally with Clinical Development, Biostatistics, Medical Affairs, CROs, and external partners to ensure aligned, inspection-ready safety strategy execution.

• Oversaw global clinical studies, ensuring compliance with company standards and regulatory requirements, including ICH-GCP, to uphold integrity and quality of research.
• Cultivated and sustained professional relationships with Key Opinion Leaders (KOLs), investigators, and professional societies to enhance organizational representation and advance scientific reputation in dermatology.
• Partnered closely with U.S. Drug Safety/Pharmacovigilance to manage clinical trial adverse events and post-marketing safety data, including evaluation and communication of emerging safety signals.
• Led the scientific review and approval of Investigator-Sponsored Trial (IST) concepts and protocols in accordance with internal SOPs and governance processes.
• Identified evidence gaps across the development and post-marketing continuum and informed the execution of integrated evidence-generation strategies.
• Directed medical strategy for scientific engagements and communications with key stakeholders, institutions, and strategic partners to align external initiatives with organizational goals.
• Maintained current knowledge of scientific and clinical advances through continuous literature review, participation in scientific congresses, professional associations, and medical forums.
• Whippany, NJ

• Conducted thorough review of scientific literature, validated safety signals and lead safety signal assessments, and developed core safety information (core data sheet, core risks in informed consent forms, etc.).
• Reviewed Evweb/Eudravigilance cases and led medical assessments of SUSAR, AOSE, and adverse events of special interest to ensure compliance and safety standards.
• Performed medical review of individual case safety reports from clinical trials, literature, and post-marketing studies to determine event seriousness and expectedness.
• Developed and reviewed core and regional risk management plans, incorporating additional risk minimization measures to enhance patient safety.
• Compiled safety protocols, statistical analysis plans, and clinical study reports to support regulatory submissions and maintain data integrity.
• Conducted reconciliation of cases between Eudravigilance database and Argus.
• Supported product registration and renewal activities.
• Morris Plains, NJ

• :
• 1. Spearheaded global clinical development programs from early development through phase 3, integrating medical and scientific objectives.
• 2. Provided strategic medical leadership across the product lifecycle, translating strategies into actionable clinical plans.
• 3. Oversaw trial execution and data integrity, ensuring adherence to timelines and milestone delivery.
• 4. Monitored trial safety in collaboration with pharmacovigilance, ensuring compliance with SAE reporting and benefit-risk oversight.
• 5. Authored and reviewed clinical documents, including protocols, investigator brochures, and regulatory submissions.
• 6. Served as medical lead on cross-functional teams, aligning medical strategy with operations and regulatory requirements.
• 7. Acted as clinical representative in regulatory interactions, ensuring compliance with GCP and SOP standards.
• 8. Engaged investigators and key opinion leaders to support protocol feasibility and scientific positioning.

• Led safety and risk management of oncology products, generated aggregate data reports for data integrity, supported clinical study protocols, and communicated recommendations to labeling group.
• Facilitated Internal Safety Monitoring Committees (SMC) meetings, provided input to SMC Charters, and represented SMT in Company Safety Committee (CSC) meetings.
• Documented and reviewed safety sections of clinical documents, ensuring accuracy of safety protocols.
• Chaired Safety Management Team (SMT) meetings for assigned products and reviews of SMT materials.
• Provided input for development and review of safety reports, including DSURs, IND reports, and benefit-risk assessments.
• Involved in escalation of non-compliance to the EEA QPPV and Head of GPV.
• Negotiated contract terms with Merck Pharmaceuticals in Rahway, NJ

• Supported consumer health products and cardiology drugs in contract role with Pioneer Data Systems.
• Assessed post marketing safety data and generated aggregate reports (PSUR, DSUR, CTPR).
• Led team in completing CAPA documents and implementing mitigation strategies.
• Adhered to best clinical practices and regulations.
• Reconciled safety data to ensure comprehensive capture of all adverse events.
• Worked on safety data on different databases (Argus AND SCEPTRE).
• Vendor: Johnson & Johnson – Morris Plains, NJ

• Processed SUSAR cases from clinical trials and ICSRs from post-marketed literature, ensuring accuracy and consistency throughout system workflow stages.
• Generated queries using ARGUS interface for clarification and resolved issues before forwarding to the next workflow.
• Contributed to safety sections of IND and NDA documents, enhancing overall regulatory submissions.
• Utilized ARGUS features such as action items, contact log, and worklist to facilitate communication and manage follow-up requests effectively.
• Medical review of Protocols and Informed consents.
• Managed remote contract responsibilities

• Received, documented, and processed SUSAR from clinical trials and post-marketing, ensuring compliance with company SOPs.
• Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines.
• Processed cases with high accuracy and consistency throughout various stages of system workflow, contributing to quality and reliability of safety data.
• Prepared comprehensive clinical narrative summaries for AE reports from clinical studies and post-marketing, enhancing clarity and understanding of safety profiles.
• Contract / Remote/onsite

• Conducted safety risk analyses on Argus version 4.2, authored clinical study protocols, evaluated causality assessments, and managed individual case safety report activities.
• Functioned as Product Safety Management Team Lead for business and research units.
• Collaborated with Regulatory, NDA Submission, Labeling, Laboratory, and sales teams to support compliance and streamline processes.
• Monitored product performance during dermatological studies to ensure safety and efficacy.
• Oversaw operations in Clark, New Jersey, ensuring adherence to regulatory standards and operational efficiency.

• Managed clinical trials for Johnson & Johnson and Parexel, ensuring compliance with regulatory standards.
• Oversaw informed consent process and maintained site master file, validating causality assessments for adverse effects and serious adverse effects to ensure participant safety.
• Obtained, processed, and shipped serum and blood specimens, contributing to the integrity of study results.
• Participated in project and investigator meetings.
• Conducted research in New York

• Led clinical trial for mifepristone and olanzapine to assess drug efficacy and safety.
• Coordinated project support activities in India to facilitate trial execution.
• Reviewed clinical trial protocols for compliance and safety standards.
• Monitored patient safety data during ongoing clinical studies.
• Collaborated with cross-functional teams to address study-related issues.

• India
• Managed critical care protocols for diverse patient populations in a high-pressure environment.
• Collaborated with multidisciplinary teams to coordinate patient treatment plans effectively.
• Conducted comprehensive assessments and diagnostic evaluations of critically ill patients.