Pharmacovigilance Associate
Core
Support medical information inquiries, adverse event reporting, and product quality complaints to ensure the safety and regulatory compliance of ophthalmic drug products.
Role type
Pharmacovigilance Associate
Builds
Individual Case Safety Reports (ICSRs) and safety communications for FDA and global regulatory authorities
Domain
Pharmaceuticals / Ophthalmics / Pharmacovigilance
Required skills
Adverse event assessment, ICSR processing, MedDRA coding, Regulatory reporting (E2B(R3)), Stakeholder engagement
Preferred skills
None stated
Technologies
E2B(R3), Safety databases
Responsibilities
Assess adverse event reports for validity and seriousness; Process new and follow-up Individual Case Safety Reports (ICSRs) including MedDRA coding; Engage with healthcare professionals to gather additional information; Support timely submission of expedited and non-expedited ICSRs to FDA; Exchange safety information with licensing and distribution partners
