Associate Director, Pharmacovigilance
Remote work flexibility within the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Required Skills
- Microsoft Office Suite
Requirements
- PharmD or Registered Nurse (RN) degree required
- Experience in pharmacovigilance or clinical development within the pharmaceutical or biotech industry
- Proven experience reviewing adverse events and working closely with safety physicians
- Hands-on experience supporting DSMB and SRC processes and safety reporting deliverables
- Strong understanding of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines
- Proficiency in safety databases such as Argus
- Strong analytical, organizational, and communication skills
- Ability to manage multiple priorities in a fast-paced, start-up or small biotech environment
- Proficiency with Microsoft Office Suite and collaboration tools such as Microsoft Teams
Responsibilities
- Oversee pharmacovigilance activities for assigned clinical programs, ensuring compliance with global regulatory standards and internal procedures
- Review and assess adverse event reports, including serious adverse events, ensuring accuracy, consistency, and timely regulatory reporting
- Ensure high-quality safety data review and coordinate reconciliation between safety databases and clinical trial data systems
- Contribute to the preparation and review of clinical study documents, including protocols, investigator brochures, and clinical study reports
- Lead and support the planning, coordination, and execution of DSMB and Safety Review Committee (SRC) meetings, including materials preparation and documentation
- Collaborate with safety physicians on signal detection, risk assessments, and benefit–risk evaluations
- Contribute to aggregate safety reporting, including DSUR preparation and related regulatory submissions
- Serve as a safety subject matter expert for internal teams and external stakeholders
- Ensure proper documentation and oversight of pharmacovigilance quality events, including deviations, CAPAs, and change controls
- Maintain accurate meeting records, safety documentation, and compliance with global pharmacovigilance regulations
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