Medical Writer III (Pharmacovigilance)
Core
Author, review, and quality check regulatory and pharmacovigilance documents including PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans.
Role type
Senior IC medical writer (pharmacovigilance)
Builds
Regulatory safety reports and risk management plans for pharmaceutical clients
Domain
Life Sciences / Pharmacovigilance
Required skills
Regulatory writing, pharmacovigilance document authoring, safety data analysis, client relationship management, mentoring junior writers, process improvement
Preferred skills
Masters or PhD in MD, pharmacy, or Life Science, experience in CRO environment, fluency in an additional language
Technologies
PSURs/PBRERs, PADERs, ACOs, DSURs, Risk Management Plans
Responsibilities
Author and review regulatory documents, ensure scientific accuracy and regulatory compliance, collaborate with cross-functional teams on safety data, act as trusted client contact, mentor junior writers, contribute to process improvements
Seniority
Mid-level, hands-on IC with mentoring responsibilities