Associate Director, Safety Science & Epidemiology

Seattle Genetics   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 58 days ago

This job is no longer available.

Summary:

The Associate Director, Drug Safety Science and Epidemiology - Reporting to the Head of Safety Surveillance and Epidemiology in Drug Safety has the primary responsibility for the support of signal management and epidemiology activities for medical products under development or post marketing.


Conducts aggregate analysis for signal detection, signal analysis, signal evaluation and risk management.

Responsibilities:

  • Support safety surveillance activities and contribute to safety analysis and risk management planning for designated products
  • Track, detect and evaluate safety signals in consultation with the Safety Evaluation and Risk Management (SERM) leads
  • Prepare safety evaluation reports for safety signals or other issues (e.g., product quality)
  • Support the preparation and maintenance of safety sections of Company Core Data Sheet, Investigator's Brochure and ICF for assigned products
  • Prepare and review periodic aggregate safety reports (PADER, PSUR/PBRER, DSUR, IND Annual Report, 6-month line-listings)
  • Support SERM lead in the development and/or execution of RMP, REMS, and benefit risk analysis
  • Contribute to safety content in the review of clinical protocols and study reports, as needed
  • Support the SERM Lead in responding to RFIs for assigned product(s) from regulatory authorities, affiliates and other cross-functional teams
  • Represent Drug Safety in cross-functional team meetings for designated product(s)
  • Attend weekly internal safety meetings (Safety Surveillance & Epidemiology and Global Safety Team meetings to discuss safety concerns and analytic plan
  • Support the SERM Lead in responding to safety requests for assigned product(s) from regulatory authorities, affiliates and other internal functions
  • Represent Drug Safety in cross-functional team meetings for designated product(s)
  • Attend weekly internal safety meetings (Safety Surveillance & Epidemiology and Global Safety Team) and cross-functional meetings to discuss safety concerns and analytic plan
  • Present signal analysis strategy and results to joint safety meetings with co-license partners

Qualifications:

  • Medical/Clinical degree including MD, PharmD, PhD/MPH, or BS RN degree
  • Minimum of 7-10 years of industry experience in drug safety and risk management
  • Oncology therapeutic area experience is preferred
  • Experience as a safety epidemiologist or appropriate epidemiology qualification will be desirable
  • Good Knowledge of US and EU drug safety and pharmacovigilance regulatory guidance
  • Good knowledge of drug safety/pharmacovigilance practices and tools (e.g., ARGUS database, TIBCO Spotfire, MedDRA, Medidata)
  • Good medical and scientific judgment, attention to detail and excellent interpersonal skills, including the ability to work effectively cross-culturally and cross-functional
  • Prefer experience in managing projects and direct reports and, independently