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- Conduct Sponsor oversight and ICSR medical reviews in both post-marketing and clinical trial settings.
- Generate outputs from the Safety Database as needed for aggregate reports and ad hoc requests.
- Perform coding review of adverse events and medical history in clinical databases for client products and studies
- Author aggregate safety reports such as the DSUR, PADER, PBRER, PSUR, etc.
- Represent Medical Safety in clinical study team meetings for all products.
- Review and develop Medical Safety SOPs and Work Instructions.
- Contribute to the development of risk management plans and REMs if needed.
- Support safety surveillance/pharmacovigilance activities such as signal detection and validation, Safety Review Team meetings (SRT), and Global Safety Committee (GSC) meetings. This includes Signal monitoring/ tracking, scheduling of SRT and GST meetings, drafting of signal detection reports.
- Review and revise medical safety science-related sections in study protocols, periodic reports, and Regulatory Agency submission documents.
- Review revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective.
- Works closely with Medical Safety Operations to provide medical input on an as needed basis.
- Review and assess literature search results.
- Supports activities related to PV-specific inspection readiness by creating procedures and processes for Safety Science activities.
- M.D. or PharmD required
- 8+ years of Drug Safety or Pharmacovigilance experience in both the clinical trial and post-market settings
- Experience in medical review of ICSRs and safety surveillance activities (including but not limited to signal detection activities)
- Experience in marketing applications locally and globally (NDA, sNDA, MAA, NDS, etc.)
- Experience in authoring/ reviewing of Risk Management Plans (RMPs)
- Strong familiarity with safety databases and data retrieval tools
- Critical thinking and analytical skills
Senior Director, Medical Safety Operations - Foster, CA, United States - Milestone Technologies, Inc.
Description
** Contract-to-Hire ... Additional details available upon discussion with Recruiter
Location :
Foster City, CA (must be local and able to work onsite at least 2 days/week)
Position Overview
The Senior Director will support Medical Safety Operations activities and collaborate with PV vendors and other departments within the company such as Regulatory, Clinical Operations, Medical Writing, Data Management, Quality, and Medical Affairs.
Primary Accountabilities :
Qualifications :