About the Role
About the Role
This role is ideal for experienced PV Operations professionals who can independently manage safety activities, mentor junior team members, and contribute to process optimization in global pharmacovigilance programs.
Key Responsibilities
Independently manage ICSR processing, medical review coordination, and case submissions.
Lead SDEA activities, including signal tracking and safety evaluations.
Drive Safety Database (SDB) optimization, reconciliation, and data quality initiatives.
Author, review, and implement PV SOPs and work instructions.
Support vendor oversight, safety metrics, and compliance reporting.
Act as a point of contact for internal and external safety stakeholders.
Requirements
5–10 years of experience in PV Operations / Drug Safety.
Strong expertise in ICSR management, SDEA, and SOP governance.
Hands-on experience with leading safety databases (e.g., Argus, ARISg, etc.).
Experience supporting audits and inspections.
Ability to work independently in a hybrid, global delivery model.