Jayson Panetta
Whitestone,NY
Summary
Strategic leader in pharmacovigilance and safety data initiatives. Enhanced patient safety through innovative signal detection and cross-functional collaboration. Trained and mentored teams to ensure compliance with ICH regulations while optimizing processes for improved outcomes.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Group Lead, Safety Data Sciences (Neuroscience, Specialty Medicine, and Eye Care)
Abbvie
07.2023 - Current
- Lead and manage the Safety Data Science group responsible for utilizing data-driven approaches to enhance patient safety and pharmacovigilance.
- Oversaw multidisciplinary team of data scientists to deliver actionable insights that informed drug safety decision-making.
- Develop and implement analytical strategies to assess, interpret, and visualize safety data from clinical trials and post-market sources.
- Collaborated cross-functionally with medical, regulatory, and IT teams to integrate, analyze, and report safety data effectively.
- Led projects to automate safety data workflows, improving accuracy in safety surveillance.
- Ensure compliance with regulatory guidelines and internal standards for safety data analysis and reporting.
Director, Safety Data Sciences Strategist and Trainer
Abbvie
01.2022 - 07.2023
- Identified training needs and trained new safety scientists while mentoring established colleagues to enhance team expertise.
- With the Team Leads, serves as a key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses across the AbbVie portfolio.
- Oversaw safety data scientists and contract support personnel to ensure alignment with project goals and enhance data integrity.
- Provided strategic guidance for collaboration in preparing and maintaining safety sections of SDS deliverables, ensuring compliance and clarity.
- With Team Leads, assures deliverable alignment to current company standards and global regulations for products/compounds.
- Supported Team Leads to utilize medical judgment to determine the impact of safety issues on the product’s benefit-risk profile.
- Led safety-related activities and initiatives within PPS and collaborated with external partners to enhance safety protocols.
- Developed a comprehensive guide on authoring safety sections to standardize practices and improve documentation quality.
Director, Safety Data Sciences (SDS) Team Lead
AbbVie (Formerly Allergan Plc, Actavis, and Forest Laboratories, Inc.)
01.2015 - 01.2022
- Manage a team (7-11 people) that is responsible for writing, coordinating, and reviewing documents pertaining to clinical data and post-marketing safety data to support product development, license application, and post-marketing maintenance, while managing the cross-functional project teams (PSURs,/PBRERs RMPs, DSURs, NDA PADERs, Clinical Overviews, RMPs, etc.). Roughly 80 products.
- Developed surveillance strategies for entire portfolio.
- Managed team for signal detection and management activities, including internal safety database review and analysis of FDA AERS and WHO Vigibase datasets via Empirica, ensuring timely and accurate reporting.
- Developed and executed safety surveillance strategy for entire product portfolio, ensuring compliance and proactive risk management.
- Served as subject matter expert for regulatory inspections, internal audits, and partner audits for the safety analysis and risk management department.
- Prepared compliance matrix for aggregate reports and signal detection, identified root causes of late reports, and developed corrective actions to enhance reporting timelines and compliance.
- Perform review of all aggregate reports and signal detection activity produced by my team.
- Oversaw management of the aggregate report, RMP, and signal detection calendar to streamline reporting processes.
- Led harmonization teams for aggregate reports and signal detection across 5 legacy companies, streamlining processes for New Allergan Company and facilitating AbbVie/Allergan integration.
- Acted as the SME to review new surveillance database and tools for future signal detection at AbbVie.
- Authored key harmonized SOPs, work instructions, and guidance documents (i.e. Signal Management and Aggregate Reports SOPs and related Work Instructions).
- Harmonized and developed (authored) the aggregate reports and signal management templates (i.e. PSUR template, PBRER template, DSUR template, Signal assessment report template).
- Developed and implemented aggregate report, signal detection, and RMP trackers, facilitating improved oversight and management of departmental activities.
- Negotiate and manage vendors. Developed strategy (i.e. chose deliverables to outsource, trained outsourcing unit, reviewed output, approved invoices).
- Contributed to ARGUS and BOXI data migration projects that focused on aggregate reports and signal detection.
- Interpreted complex regulations (GVP module and ICH) to develop search strategies in BOXI.
- Co-Lead the Signal Management work package as part of an end to end optimization project aimed to address gaps, audit and inspection findings, and evaluate current tools.
- Served as safety lead for new EDMS system consolidation, developing workflows and training materials to enhance department efficiency.
- Developed the process and templates for new PADER FDA combination rule, the new EU MDR regulations, and the EVDAS pilot program.
Associate Director Safety Information Management (SIM)
Allergan Plc (Formerly Forest Laboratories, Inc.)
06.2012 - 12.2014
- Write, coordinate, and review documents pertaining to clinical data and post-marketing safety data to support product development, license application, and post-marketing maintenance, while managing the cross-functional project teams (PSURs,/PBRERs RMPs, DSURs, NDA PADERs, RMPs, etc.).
- Perform quarterly statistical signal evaluation in Empirica.
- Adjudicate signals based on underlying disease, label, and clinical knowledge.
- Conducted comprehensive workups for non-adjudicated signals, reviewing and summarizing literature, clinical data, and post-marketing reports to enhance decision-making processes.
- Conducted monthly, quarterly, and biannual trend analyses based on product level.
- Project manager and process developer of new aggregate report regulatory requirements including new EU RMP and PSUR in EMA Module VII/ICH E2C [R2] format (PBRER).
- Project manager and process developer of the annual summary report for Canada in accordance with Health Canada’s regulatory requirements - Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products.
- Contributed as core member of ARGUS integration team, ensuring successful development, migration, and functionality of PSUR, PBRER, and Canadian ASR reports.
- Served as PVRM representative on Global Alliance team, facilitating stakeholder communication and alignment on safety information management initiatives.
- Ensure Forest Laboratories, Inc. is fulfilling its regulatory requirements in all territories across the globe.
- Developed global SOPs for PSUR ICH E2C [R1], PSUR ICH E2C [R2], and Canadian ASR.
- Developed the PSURs and Canadian ASR templates.
- Ensured GDS received safety data from all subsidiaries to maintain compliance.
- Created PSUR calendar aligned with URD calendar from EMA to ensure timely compliance with regulatory reporting requirements.
- Worked with vendors as the safety point of contact.
- Worked with Safety Alliance Management group in development of PV Contracts with partners and vendors.
- Represented PVRM during audits and inspections.
- Designed and developed a web based landing page for safety that integrated all regulations, templates, and relevant links necessary to perform one’s job.
- Managing, developing, and implementing a new SOP and template for cosmetic products.
- Developed, implemented, and managed an aggregate reports calendar.
- Provide documents clearly summarizing a drug’s risk/benefit profile and guiding internal stakeholders on document strategy as they apply to product benefit-risk.
- Advised cross-functional teams on global regulatory requirements and responsibilities from a safety perspective; provided strategic guidance on clinical and safety data analysis and benefit-risk assessments.
- Presentations to executive leadership team regarding the impact of globalization as it pertains to their groups and what the expectations are for the future.
- Mentored and trained colleagues and cross-functional teams on the preparation and analysis of aggregate reports.
Safety Evaluation and Reporting Associate Director
Pfizer, Inc.
New York, USA
09.2006 - 06.2012
- Provided documents clearly summarizing a drug’s risk/benefit profile and guided internal stakeholders on document strategy related to product benefit-risk.
- Apply expert knowledge, analytical skills, knowledge of clinical and regulatory guidance and scientific and medical literacy in order to contribute to understanding and communicating risk and risk/benefit, through the preparation of essential written deliverables, in conjunction with the project team and with colleagues in Safety and Risk Management such as other analysts, epidemiologists, and authors in SRM or Worldwide Development.
- Perform analyses of clinical safety data from pre- and post-approval data sources to ensure the communication of the considered risk/benefit balance of Pfizer products in compliance with regulatory requirements.
- Ensured high-quality written presentations of integrated clinical data compliant with regulations, ICH guidelines, and corporate SOPs; implemented systems and processes to enhance compliance and suggested process improvements.
- Optimized license approval chances for Pfizer product teams through development of commercializable labels and effective post-marketing maintenance via comprehensive written deliverables.
- Fostered partnerships with Worldwide Development and safety stakeholders through strong leadership and collaborative approaches to enhance project outcomes.
- Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- Develop and sustain constructive relationships within SRM and with Worldwide Regulatory Affairs, Development Operations, Clinical Sciences, Pfizer Country Offices medical departments, Marketing and other stakeholders.
Senior Safety Surveillance Associate
Pfizer, Inc.
New York, USA
02.2005 - 08.2006
Safety Surveillance Associate
Pfizer, Inc.
New York, USA
07.2004 - 02.2005
- Review reports of adverse events on Pfizer marketed products obtained through various sources: US and international spontaneous reports (obtained from consumer, healthcare professional, Pfizer country offices, the field force, Pfizer Call Center and other suppliers), clinical trials conducted by PGP and PGRD, and literature reports.
- Assess reports of adverse events and determine reportability in accordance with FDA and ICH guidelines.
- Determine regulatory reporting requirements based on assessment of seriousness and labeling of selected event terms.
- Coordinate and track the processing of adverse event reports through the corporate safety database, AEM and ARISg, and RSGT (Regulatory Safety Group Tracking) database.
- Process expedited Med Watch and CIOMS I adverse event reports.
- Improved communication by collaborating with Worldwide Safety and Pfizer Country Offices on safety-related issues.
- Conducted database searches and extracted relevant data to generate reports for preparing aggregate reports with the Regulatory Reports Group, improving accuracy in regulatory submissions.
- Revised sildenafil expectedness guides to maintain compliance with current safety standards, ensuring up-to-date regulatory adherence.
Pharmacist
Duane Reade Pharmacy
Queens, USA
09.2002 - 07.2004
- Evaluated prescriptions for appropriateness, validity, drug interactions, contraindications, therapeutic duplications and other drug-related problems.
- Performed interventions with patients and other members of the medical staff to ensure optimal patient therapy.
- Counseled patients on prescription medications, medical devices, herbal preparations, and OTC products to ensure understanding of treatment options.
- Answered questions that were presented by patients, physicians, and other medical professionals using various resources.
- Resolved insurance claim issues to improve patient access to necessary medications.
- Trained and supervised interns and technicians, fostering a knowledgeable support team.
- Supervised and trained first and fourth year pharmacy students, imparting essential knowledge of pharmacist responsibilities.
- Compounded prescriptions accurately in a pharmacy setting.
Adjunct Assistant Clinical Professor
St. John’s University, College of Pharmacy and Allied Health Professions
Jamaica, USA
06.2003 - 06.2004
- Reviewed patient cases and prescriptions, applying physical assessment skills to uphold high standards of patient care and education.
- Evaluated students’ oral presentations, written assignments, and pharmaceutical skills, delivering targeted feedback to promote their academic growth.
- Simulated prescriber and patient roles in scenarios addressing drug-related problems in community and hospital pharmacy settings, improving students' practical understanding of clinical decision-making.
Pharmacy Intern
Utopia Pharmacy
Flushing, USA
09.1998 - 07.2002
- Processed, prepared, compounded prescriptions to ensure accurate and timely dispensing.
- Evaluated and entered patient information into profiles to ensure accurate medication management.
- Counseled patients on medications and medical devices, improving understanding and adherence.
- Collaborated with physicians and healthcare professionals to enhance patient therapy outcomes.
- Communicated with third party plans to resolve patient problems.
Education
Doctor of pharmacy -
St. Johns University College of Pharmacy and Allied Health Professions
Jamaica, New York05-2003
Bachelor of Science - Pharmacy
St. Johns University College of Pharmacy and Allied Health Professions
Jamaica, New York05-2002
Skills
- Pharmacovigilance
- Signal detection
- Regulatory compliance
- ICH regulations
- GVP regulations
- Project planning
- Strategic planning
- Cross-functional collaboration
- Stakeholder engagement
- Operational efficiency
- Team leadership
- Decision-making
- Problem solving
- Attention to detail
- Time management
- Team collaboration
Certification
New York State Pharmacist License, 048898
Timeline
Group Lead, Safety Data Sciences (Neuroscience, Specialty Medicine, and Eye Care)
Abbvie
07.2023 - Current
Director, Safety Data Sciences Strategist and Trainer
Abbvie
01.2022 - 07.2023
Director, Safety Data Sciences (SDS) Team Lead
AbbVie (Formerly Allergan Plc, Actavis, and Forest Laboratories, Inc.)
01.2015 - 01.2022
Associate Director Safety Information Management (SIM)
Allergan Plc (Formerly Forest Laboratories, Inc.)
06.2012 - 12.2014
Safety Evaluation and Reporting Associate Director
Pfizer, Inc.
09.2006 - 06.2012
Senior Safety Surveillance Associate
Pfizer, Inc.
02.2005 - 08.2006
Safety Surveillance Associate
Pfizer, Inc.
07.2004 - 02.2005
Adjunct Assistant Clinical Professor
St. John’s University, College of Pharmacy and Allied Health Professions
06.2003 - 06.2004
Pharmacist
Duane Reade Pharmacy
09.2002 - 07.2004
Pharmacy Intern
Utopia Pharmacy
09.1998 - 07.2002
Doctor of pharmacy -
St. Johns University College of Pharmacy and Allied Health Professions
Bachelor of Science - Pharmacy
St. Johns University College of Pharmacy and Allied Health Professions