About the position
The PV Scientist will play a key role in safety surveillance, signal detection, and regulatory reporting. This individual will collaborate cross-functionally to support clinical and post-marketed safety activities, ensuring compliance with global pharmacovigilance regulations and company policies.
Responsibilities
- Provide review and input for responses to Regulatory Authorities.
- Develop, refine, and utilize data analytic tools for signal management activities.
- Contribute to safety signal surveillance, evaluation, and analysis.
- Develop and implement project-specific signal detection strategies.
- Conduct in-depth evaluations of safety signals and prepare analysis reports.
- Lead strategy and preparation for quarterly ad hoc safety committee meetings, including presentation materials and communication.
- Provide safety input and review of Clinical Study Reports (CSRs), Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLFs).
- Draft safety sections for top-line results, key safety messages, and assist in writing safety narratives.
- Perform Individual Case Safety Report (ICSR) review for clinical trials and post-marketed programs.
- Generate Analysis of Similar Events (AOSE) outputs and draft AOSEs for clinical trials.
- Attend multidisciplinary project team meetings and serve as the PV Scientist lead in medical monitor meetings.
- Provide PV medical support for key safety-related documents, including Informed Consent Forms (ICF), Protocols, Investigators Brochure (IB) / Reference Safety Information (RSI) documents, Aggregate Report reviews, Case Report Form (CRF) page reviews, Clinical coding reviews, Literature extracts for medical affairs, Safety Management Plans (SMP), Safety Reporting Plans, Medical Monitor Plans, and Standard Operating Procedures (SOPs).
Requirements
- Advanced degree (PharmD, PhD, MD, or equivalent) in a life sciences-related field preferred.
- Significant experience in pharmacovigilance, safety surveillance, or related discipline.
- Strong expertise in safety data analysis, signal detection, and regulatory reporting.
- Proficiency in safety databases, EDC systems, and case processing tools.
- Excellent communication and leadership skills, with the ability to work cross-functionally.
