Reporting to the Sr. Director of Pharmacovigilance and Clinical Safety, the Safety Scientist supports both early and late phase development activities providing essential safety oversight and input into all aspects of signal management across the entire development portfolio. This role will partner closely with safety physicians and other clinical development colleagues, and contributes to safety deliverables required to manage and communicate the evolving safety profile.
- Participate in development of safety-related data collection forms for clinical studies
- Review of the safety data from clinical
- Responsible for individual case safety reports (ICSRs) medical review
- Directs the planning, preparation, writing and review of aggregate reports (e.g. DSURs)
- Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
- Search and review adverse event data, literature, and other safety-relevant data for signal detection
- Assist in the development of risk management strategy and activities
- Assist in responding to Health Authority requests and questions
- Support activities related to new drug applications and other regulatory filings
- Support the PV review of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF) statistical analysis plans and other clinical study-related documents to ensure alignment with the safety strategy and risk communication.
- Minimum of 2 years’ experience in pharmacovigilance
- Experience in signal detection, evaluation, aggregate data analysis, and interpretation
- Experience with document writing and version
- Excellent communication skills, both written and verbal
- Knowledge of Pharmaceutical dictionaries and understanding of MedDRA coding
- Experience using analytics tools (Spotfire, Tableau, etc.) preferred
- Experience in CNS drug development preferred
PhD, RN, PharmD or MD degree required
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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