Position Summary

The Manager, Drug Safety and Pharmacovigilance will report to the Director, Drug Safety and Pharmacovigilance. This individual will be responsible for processing case data, drafting safety narratives based on company templates, retrieving safety data outputs, producing listings from the safety database and meeting safety database standards. This individual will contribute to the successful completion of safety-related goals and objectives in collaboration with the clinical development team. This role requires significant safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, company processes, SOPs and Work Instructions, particularly in connection with investigational drug safety and pharmacovigilance for clinical studies.

Essential Duties and Responsibilities

  • Perform data entry and processing into ARGUS platform for single case reports (ICSR)
  • Draft safety narratives in the ARGUS DB for MedWatch and CIOMS, utilizing company templates, guidance and standard queries
  • Collaborate with clinical development functions – Clinical Operations, Data Management, Biostatistics, Regulatory and QMS
  • Use basic Oracle safety features in the retrieval of limited data safety outputs and listings based on  company processes and directions
  • Generate routine and ad-hoc safety data outputs and listings for preparation of the aggregate safety reports, such as DSUR, Investigator Brochures (IBs) and RMPs
  • Assist with relevant projects or duties as needed

Qualifications

  • Bachelor's Degree in a Life Sciences discipline required
  • Minimum 3 years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required
  • Minimum 3  years of experience as a healthcare professional, such as nurse/registered nurse preferred
  • Must have direct experience and working knowledge of safety platform ORACLE ARGUS
  • Willingness to cooperate in case of emergency, as warranted
  • Maintain high personal and professional standards
  • Understand the complexity of the drug development space, while acting at the highest level of integrity and competence
  • Previous experience in oncology preferred
  • Must have verbal and written fluency in English

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