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Description

Job Description

The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals.

Scope

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
• Assist in follow-up of important ICSRs to ensure relevant information is sought.
• Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
• Participate in the development development of safety surveillance and risk management plans for drug development programs.
• Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report).
• Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed.
• Participate in the preparation and revision of company product labeling and RMP as appropriate.
• Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents.
• Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
  
  

Deliverable (please Have Experience With)

• ICSR reviews in Argus safety database.
• Completed quarterly signal evaluation forms.
• Completed signal issue work-ups.
• Completed aggregate reports.
• Risk Management Plans.
• Slide decks for Safety Management Team/Product Safety Committee meetings.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Staffing and Recruiting

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