Monica Singh
Newtown Square
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
14
14
years of professional experience
Work History
Senior Manager, PV Scientist
Nurix Therapeutics
07.2022 - Current
- To provide safety surveillance and risk management activities for all assigned company products.
- Lead signal detection activities for all the product's emerging safety profile and proactive safety data review.
- Lead cross-functional safety team meetings (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Plan, author and compile pharmacovigilance aggregate reports (e.g., DSUR, PADER, PBRER) for all assigned compounds and ensure all safety documents are submitted according to regulatory requirements.
- Contribute to the development of a safety governance structure
- Support the authoring of clinical documents including Investigators Brochure (IB), study protocols, Informed Consent Forms (ICF).
- To analyze the current safety profile of all compounds and safety data for the RSI section of the IB.
- Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAE reconciliation, and safety reporting training.
- Represent PV in cross-functional meetings and additional activities to support clinical development programs.
- Provide support in writing and analyzing written responses to health authority requests/queries.
- Support process improvement and Cross-functional initiatives for safety science including SOPs and procedural documents.
- Provide safety reporting training to internal company employees and contracted vendors.
- Contribute to the development of safety management plans and facilitate activities during study start-up phase, including Cross-functional interactions.
- Participate in audit/inspection preparedness activities and serve as subject matter expert during regulatory inspections.
Senior Drug Safety Science Manager
Nektar Therapeutics
09.2021 - 06.2022
- Prepare aggregate safety reports (e.g., DSURs, PSURs, RMP), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and perform quality checks
- Perform routine and ad-hoc signal management/signal detection activities involving the Nektar investigational products
- Create and maintain an effective signal tracking process that fully documents signal evaluation activities and can be used for regulatory inspections
- Work on complex issues where analysis of situations or data requires an evaluation of intangibles
- Plan and execute literature surveillance
- Contribute to the preparation of CSR and BLA filings
- Organize and performs independently or collaboratively as necessary, the relevant safety data analysis for Safety Review meetings
- Support other function teams for Nektar investigational products
- Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
- Support Drug Safety activities as requested
- Serve as Drug Safety Science expert and liaise with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Management, and other entities as needed
- Contribute to health authority and other safety related query responses
- Review the informed consent form (ICF) templates to ensure alignment with protocol and the Investigator Brochures
- Support study teams for Nektar investigational products
Pharmacovigilance Scientist
Janssen Pharmaceuticals
06.2021 - 09.2021
- Oversee aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group (Covid-19 vaccine)
- Safety surveillance activities for assigned products
- Review study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information
- Signal detection, evaluation, and management
- Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Provide safety contents for risk management plans
- Assist in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations.
Medical Scientist
Otsuka America
07.2018 - 06.2021
- Maintain accurate and complete knowledge of assigned investigational and marketed products
- Collaborate and assist the medical safety staff in the identification of safety signals, analysis and authoring of safety data summaries and preparation of responses to safety inquiries from healthcare professionals, regulatory agencies and other customers
- Signal detection/evaluation activities including authoring of Signal Evaluation Reports, maintenance of safety signal tracker
- Safety surveillance of the EudraVigilance Data Analysis System (EVDAS), WHO Vigibase, & FAERS
- In conjunction with medical safety staff, assist the team with analysis and authoring of specific sections for pre and post-marketing aggregate reports and other key safety documents, including IND, NDA, SUSAR LL, PADER, PBRER/PSUR, DSUR, etc
- Collaborate with global medical safety physicians to select and analyze data from Argus
- Collaborate with global medical safety physicians (or CRO) in the development of safety content by applying knowledge of safety profiles; conduct literature searches and summarize relevant findings
- Coordinate with other cross-functional stakeholders in development of content, review and finalization of documents, including relevant Global PV counterparts
- Collaborate with Medical Safety Staff to become familiar with risk management plans (RMPs) and regulatory guidance documents; assist medical safety staff with the development and/or authoring of safety sections of RMPs, and other regulatory submissions
- Assist with quality assurance of clinical study safety data (tables and listings reviews, etc.)
- Participates with the Medical Safety staff in Medical Safety Review Team (MSRT) meetings for assigned products; provides inputs in meeting minutes and follow-up
- Along with medical safety staff, represent Global Medical Safety via active participation in cross-functional meetings and committees; consults and shares expertise within Global PV and with multiple stakeholders
- Follow procedures to drive quality, timeliness, and compliance with regulations
- Expand knowledge of and uses computer software programs to assist with data capture
- Participate in departmental and inter-departmental meetings and committees, and process improvement work-streams, as appropriate.
Pharmacovigilance Scientist
Alkermes
07.2017 - 06.2018
- Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor
- For investigational product(s): safety review of protocol and CRFs, safety content of IB, ICF, and as appropriate support DSMB activities
- Assist with lab and AE data review, associated with clinical study reports
- Collaborate on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
- Facilitate signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and evaluate safety data and signals as part of on-going pharmacovigilance activities
- Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities
- Drafting and review of the PV Plans and Integrated Safety Summary Reports
- Trending analysis of clinical trial oncology drugs, preparing macro enabled Excels and Pivot tables
- Conducting cross functional meetings, documenting and training the team according to the project requirements
- Working closely with Medical Safety Physicians (MSP) and mentoring the Pharmacovigilance team as required
- Responsible for signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff
- This includes performing signal investigations and drafting signal investigation reports
- Actively identify and monitor the safety profiles of investigational and post-marketed products
- Write justification documents to support product labeling decisions
- Research, prepare, and present background documents and case materials for discussion at interdepartmental safety review meetings
- Research and prepare written responses to safety queries from worldwide regulatory authorities, foreign affiliates, healthcare professionals, and internal customers
- Safety Committee preparation and documenting of meeting minutes
- Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.
Periodic Report Associate
Genzyme, a Sanofi Company
07.2015 - 06.2017
- Lead the preparation of Periodic Safety Reports (PSR) in compliance with regulatory requirements such as GPVP, ICH, FDA and Global Quality standards within established timelines
- Author and lead the periodic safety reports process for international submission including Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Bridging Reports (BR), Addendum Reports (AR), Semi-Annual Safety Reports (SASR), Periodic Adverse Drug Experience Reports (PADER) and Addendum to Clinical Overview (ACO)
- Provide contributions to safety related sections of Development Safety Update Reports (DSUR), IND Annual Report (INDAR) in close collaboration with the Global Safety Officer (GSO) in order to convey a concise and well-founded safety message
- Provide Medical writing contributions to regulatory documents including; Risk Management Plans (RMP), Clinical Overviews, responses to Regulatory Authority (RA) assessment reports and submission dossier requirements
- To ensure oversight/management of outsourced vendor for PSR authoring to ensure timely and quality report completion
- To perform the consistency checks for Corporate PBRERs, ACOs for quality compliance
- To ensure quality and continuous improvement for periodic reporting activities
- Maintain and monitor the timeline compliance of all the upcoming PBRERs
- Quality check the PBRERs for consistency and performs quality tracking in the quality tracker
- Monitor the weekly table with list of Periodic Safety Reports (PSR) distributed during each week
- Responsible for the drug safety documentation archiving in accordance with corporate records management policies and archive room maintenance.
Drug Safety Research Analyst
AdverseEvents Inc.
01.2015 - 04.2015
- To perform data mining from FDA Adverse event Reporting System (FAERS)
- Conduct online research & update the AE database with new, real-time drug safety related information
- Support ongoing efforts to monitor and analyze post market regulatory news via regulatory intelligence
- Participate, propose and assist in writing white papers, research publications and other client materials
- Responsible for label mining, reviewing and investigating prescribing information for marketed drugs
- Conduct post-market analysis of safety data for newly approved drugs with already marketed drugs
- Writing intensive Drug Safety Monitoring (DSM) articles with critical safety insight.
Safety Surveillance & Regulatory Writer (Intern)
Regulatory Doctor
08.2014 - 12.2014
- Author/contribute to evaluate and prepare the core safety deliverables for pharmaceutical products
- Coordinate to perform reconciliation activities related to post market safety deliverables
- Writing clear and concise clinical documents like summary documents, scientific articles etc
- Peer review of scientific journals and writing review articles for understanding the safety of the product
- Support the evaluation of current processes and assess alignment with current regulations/guidelines
- To ensure compliance with regulatory reporting rules worldwide and ICH requirement
- Conducted market research to analyze medical devices and their trends as per MAUDE.
Senior Drug Safety Specialist
APCER Pharma
02.2014 - 08.2014
- Prepare timely Pharmacovigilance reports for products and safety issues, including ICSRs for AE/SAE
- Train in assisting in preparation of Annual reports and PSURs from line listings extracted from ARISg
- Review and reconcile serious adverse event (SAE) data between clinical and safety databases
- Traine newly joined safety team members in all aspects of case-handling and adverse event reporting
- Ensure compliant safety reporting in accordance with US and international reporting regulations
- Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- Entry of safety data onto ARGUS and code adverse events accurately using MedDRA
- Assist in compilation of regulatory submissions for spontaneous and clinical cases
- Determine expectedness/listedness against appropriate label and write patient narratives.
Senior Drug Safety Specialist
Synowledge LLC.
09.2012 - 12.2013
- Ensure accurate collection, recording, reviewing and reporting of literature searches from line listings
- Literature review and analysis of known and potential risks defined in the SOP and regulations
- Preparation of Summary Case Reports for expedited reporting and data processing into agXchange
- Review of literature articles from DERWENT, MEDLINE & EMBASE databases for ICSRs
- Ensure quality of literature searches and determine regional report ability
- Investigate the potential signal detection cases and communicate to appropriate departments
- Reconciliation of study summary documents for validity assessment, triaging and case processing
- Training and development of new joiners for global literature review and case processing
- Processing and quality check of Adverse Events (AE) for listedness/expectedness for medical review
- Processing of SUSARs on an expedited basis complying as per SOP and required regulations
- Process and distribute safety reports received from any source for assigned products and/or studies
- Coding all medical history, events, drugs, and lab tests as per MedDRA, CPD & WHO-DD.
Pharmacovigilance Officer
Wipro Technologies
04.2011 - 08.2012
- Process adverse event information and assist in the preparation of internal and external reports
- Triage incoming cases to determine seriousness for processing and reporting prioritization
- Perform accurate data entry of identified adverse event information into ARGUS, IRMS
- Uniform timely processing and reporting of adverse events to the FDA and other regulatory bodies
- Patient handling on spontaneous calls and collect adverse event information for potential ICSRs
- Initiate case follow-up activities for completeness and consistency through follow-up letters
- Perform quality control activities to ensure complete and accurate case information entered in ARGUS
- Act as a liaison with internal departments and external business partners.
Associate Industrial Trainee
Albert & David’s Co Pvt Ltd
03.2010 - 08.2010
- Gained Knowledge on the functioning of various production & analytical sections
- Handled various analytical apparatus like DT tester, dissolution apparatus etc
- Trained on various production sections of tablets, capsule, and syrup, injectable & packaging.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA05.2016
Post Graduate Diploma in Advanced Clinical Research (PGDACR) - Clinical Research
Institute of Clinical Research, India (ICRI)
Delhi, India04.2011
Bachelor of Science - Pharmacy
Uttar Pradesh Technical University (UPTU)
Lucknow, India06.2010
Skills
- Signal detection analysis
- Signal Management
- Aggregate Reports (PSUR, DSUR, PADER, etc)
- Adverse event reporting
- Pharmacovigilance regulations
- Medical literature review
- Post-marketing surveillance
- Safety Management
- Strong analytical thinking
- Data analysis expertise
- ARGUS & ARISg
- Empirica, Tableau, Spotfire
- Risk Management Plan
projects and presentations
- Comparison of Causality Assessment using various causality assessment scales
- Nanosuspensions
paper publications
- Review article “Food Drug Administration vs. European Union” in Drug Designing Journal available at: [link]
- Review article “Clinical Trials Outsourcing: Good or Bad?” in Drug Designing Journal available at: [link]
References
References available upon request.
Timeline
Senior Manager, PV Scientist
Nurix Therapeutics
07.2022 - Current
Senior Drug Safety Science Manager
Nektar Therapeutics
09.2021 - 06.2022
Pharmacovigilance Scientist
Janssen Pharmaceuticals
06.2021 - 09.2021
Medical Scientist
Otsuka America
07.2018 - 06.2021
Pharmacovigilance Scientist
Alkermes
07.2017 - 06.2018
Periodic Report Associate
Genzyme, a Sanofi Company
07.2015 - 06.2017
Drug Safety Research Analyst
AdverseEvents Inc.
01.2015 - 04.2015
Safety Surveillance & Regulatory Writer (Intern)
Regulatory Doctor
08.2014 - 12.2014
Senior Drug Safety Specialist
APCER Pharma
02.2014 - 08.2014
Senior Drug Safety Specialist
Synowledge LLC.
09.2012 - 12.2013
Pharmacovigilance Officer
Wipro Technologies
04.2011 - 08.2012
Associate Industrial Trainee
Albert & David’s Co Pvt Ltd
03.2010 - 08.2010
Master of Science - Regulatory Affairs
Northeastern University
Post Graduate Diploma in Advanced Clinical Research (PGDACR) - Clinical Research
Institute of Clinical Research, India (ICRI)
Bachelor of Science - Pharmacy
Uttar Pradesh Technical University (UPTU)
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