Drug Safety Physician (MD)
Drug Safety Physician (MD)
As Clinical Safety Physician, he/she will be responsible for providing ongoing medical evaluation/review and assessment of the risk-benefit profile for our drugs in development, while managing all safety issues and regulatory requirements/submissions in collaboration with pharmacovigilance (PV) vendor.
The Drug Safety Physician reports to the Head of Pharmacovigilance (PV), and interacts closely with the Global Clinical Development, Biostatistics, Quality Assurance and Regulatory Science functions.
- Responsible for the development of overall risk management plans, pharmacovigilance strategies and risk minimizations activities
- Accountable for signal detection, evaluation and decision-making across the lifecycle of the compound(s).
- Review and design of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
- Oversee medical assessment of individual case safety reports from investigational as per applicable SOPs, safety product/project plan, and according to regulatory reporting timelines in collaboration with external service providers
- Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR), and other Safety Reports) and benefit-risk assessments
- Proactively assesses and evaluates the clinical implications of safety data from all sources (including pre-clinical studies, clinical studies, literature, registries) in order to expertly understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing setting as appropriate. Participates in monthly data reviews with the clinical team.
- Participate in and provide input for independent Drug Monitoring Committees (iDMC)
- Represent PV in clinical team meetings, and provide strategic input to safety-related topics
- Support Health Authority Inspection, in particular those with focus on drug safety
- Manage CRO, and investigational site personnel regarding PV as appropriate
- Conduct all PV activities for our development compounds, including medical assessment, ongoing safety evaluation and signal detection
- Medical degree (M.D./D.O or equivalent) required
- Minimum of 3 years of clinical experience in the industry setting
- Experience in Clinical Safety, Pharmacovigilance and risk management is required
- Excellent communication, writing and analytic skills required
- Direct experience in CNS area strongly preferred
- Board Certification or equivalent strongly preferred
Medical degree (M.D./D.O or equivalent) 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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