Associate Director, Pharmacovigilance

Location

Pennsylvania

Posted

2 days ago

Salary

Not specified

Seniority

Senior

Postgraduate Degree6 yrs expEnglish

Job Description

• Support the daily management and execution of pharmacovigilance operations. • Ensure compliance with regulatory requirements, PV agreements, and internal SOPs. • Contribute to the oversight of drug safety activities and cross-functional safety initiatives. • Assist in developing, implementing, and maintaining PV processes, SOPs, and quality standards. • Support oversight of adverse event (AE) collection, review, and reporting. • Participate in the medical review process for ICSRs, as appropriate. • Support preparation of periodic safety reports (PSURs, DSURs) and benefit-risk assessments.

Job Requirements

  • Advanced degree in medicine, pharmacy, nursing, or related scientific field preferred.
  • Minimum of 6–8 years of experience in drug safety operations (case management, signal detection, risk management, regulatory reporting).
  • Experience working with external vendors/CROs required.
  • Experience in cardiovascular disease and post‑marketing PV activities preferred.
  • Strong communication, collaboration, and organizational skills.
  • Proficiency with safety database systems and PV software tools.

Benefits

  • health insurance
  • dental and vision coverage
  • term life and disability coverage
  • retirement plans

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