Senior Associate, Aggregate Reporting Physician
ClinChoiceYerevanFull TimeHealthcare
Remotely
pharmacovigilanceregulatory writingpsurpbrericsrdsur
Job Description
📋 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