Drug Safety Science, Associate Director

Seattle Genetics   •  

Bothell, WA

Industry: Biotech/Pharma

  •  

8 - 10 years

Posted 352 days ago

Description

Summary:

Safety Scientist is responsible for carrying out pharmacovigilance and risk management activities for assigned product(s). The Safety Scientist supports Safety Surveillance (SS), Safety Evaluation and Risk Management (SERM) activities in aggregate analysis and single case evaluation for signal detection, signal analysis, signal evaluation and risk management.

 

Responsibilities:

  • Support Safety Surveillance activities, contribute to Pharmacovigilance and Risk Management planning for designated products
  • Track, detect and evaluate safety signals in consultation with SS and SERM leads
  • Prepare Safety EvaluationReports as necessary for safety signals or other issues (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 the SERM lead in the development and/or execution of RMP, REMS, and Benefit risk analysis
  • Provide safety content in and review of clinical protocols, study reports, ICFs and Investigator Brochures, as needed
  • Support the SERM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates and otherinternal functions
  • Represent Drug Safety in Study Team Meetings and/or Clinical Sub Team Meetings for designated product(s)
  • Attend weekly internal safety meetings (Safety Surveillance & Epidemiology and Global Safety Meetings) and cross-functional meetings (Study Team/Clinical Sub Team Meetings) to relay safety concerns raised in the clinical study meetings
  • Participate in joint safety meetings with co-license partners

 

Qualifications:

  • Medical/Clinical degree including MD, PharmD, BS Pharmacy, PA, or BS RNdegree
  • Minimum of 7-10 years of industry experience in drug safety and risk management
  • Oncology safety science experiencepreferred
  • Good Knowledge of US and EU drug safety and pharmacovigilance regulatory requirements
  • 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 ability to work effectively cross culturally and cross functionally