Senior Associate, Aggregate Reporting Physician

Added
9 hours ago
Type
Full time
Salary
Salary not provided

Related skills

pharmacovigilance regulatory writing psur dsur pbrer

πŸ“‹ Description

  • Develop, review, and maintain pharmacovigilance docs for consumer health products.
  • Synthesize safety data from multiple sources (ICSRs, aggregate data, trials, post-marketing data
  • Prepare PSURs/PBRERs/PADERs and related safety reports for regulatory submissions.
  • Support risk management docs, safety narratives, and SMT safety analyses.
  • Collaborate with Safety Scientists, Medical Reviewers, and other teams to assess safety information.

🎯 Requirements

  • Advanced degree (PharmD, PhD, MD, MPH, MS or equivalent).
  • 3–6 years in pharmacovigilance, drug safety, or related fields.
  • Experience with regulatory writing and pharmacovigilance docs preferred.
  • Strong knowledge of global pharmacovigilance regulations and safety reporting.
  • Excellent medical writing, editing, and presentation skills.
  • Proficient in MS Office; strong formatting and data presentation.

🎁 Benefits

  • Flexible Working Hours
  • Full performance and development process with end of year reviews
  • Team events and end of year party
  • Employee satisfaction survey - feedback valued
  • Health Insurance
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