Description:
Department: Clinical Safety
Job Category: Clinical
Job Title: Director, Clinical Safety
Duties: Job Title: Director, Clinical Safety Job Schedule: Candidate can work 100% remote for duration of assignment; might need to come into office for occasional meetings (once a quarter). Candidates need to be EST based.
Incumbent will be responsible for responses to Health Authority inquiries on safety issues and prepares safety data for health authority review boards.
Present safety data in SMTs as a recognized product safety expert and serve as the CSPV functional rep at Global multifunctional project team meetings.
This position prepares, summarizes, and reviews aggregate safety analyses.
Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III.
This position performs safety assessments and determines the safety profiles of assigned products.
This position also works with other CSPV staff to assess new signals/risks emerging from post marketing data.
This position may review and approve safety documents.
Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active development, submission phase and during marketing phase.
Safety Expert – Overall: Serves as the physician responsible for safety profile and for leading SMTs for post marketing safety data from assigned products.
Defines the risk component of the B/R assessment.
Safety Expert – Signal Evaluation: Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets.
Safety Expert – Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities.
Proposes risk mitigation solutions to management and SMT.
Reports and Submissions: Contributes to and reviews safety sections of the NDA, CSR, and IB.
Skills: 3-5 years of Pharmacovigilance (PV)/drug safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work.
Demonstrated ability to prioritize work, implement strategy and processes, collaborate with others.
Keywords:
Education: MD Degree Required
Skills and Experience:
Required Skills:
DRUG SAFETY
PHARMACOVIGILANCE
CLINICAL SAFETY
MITIGATION
DATASETS
Additional Skills:
SURFACE MOUNT TECHNOLOGY
REGULATORY DOCUMENTS
CSR
TRADING
NDA
SMT
MARKETING
Languages:
English
Read
Write
Speak
Minimum Degree Required: Master's Degree

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