Job Title : Associate Director, Clinical Safety MD
Job Schedule : Candidate can work % remote for duration of assignment. EST / CST time zone-based candidates preferred.
Position supports safety monitoring and risk management activities for products in development. This position will work closely with a senior physician.
Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members.
Responsibilities
- Signal Identification and evaluation : Carries out routine signal identification and evaluation activities for assigned products in development phase
- Risk Mitigation & Communication : Communicates any safety concerns to management and relevant team members.
- Responsible for responses to Health Authority inquiries on safety issues and prepares safety data for safety review boards.
- Present safety data in SMTs as a product safety expert
- Prepares, summarizes, and reviews aggregate safety analyses.
- Performs safety assessments and determines the safety profiles of assigned products.
- Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, CSR, Clinical Overview and Integrate safety summary) required during active development, and submission phase.
- Defines the risk component of the B / R assessment.
- years of Pharmacovigilance (PV) / clinical safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work.
Demonstrated ability to implement strategy and processes and collaborate with others. Safety experience in clinical development preferred.
Experience in rare disease is a plus.
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