Assistant Manager/Deputy Manager-Pharmacovigilance

Minimum of 8 years experience in handling Aggregate reports such as PBRERs/PSURs, PADERs, RMP and Signal Management reports.

• To lead the aggregate reporting team, and to schedule and ensure regulatory compliance in preparation, review and reporting of aggregate reports (PADERs and    PBRERS/PSURs), signal reports, risk management plan reports.

• To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports.

• Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role.

• To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety.

Qualification: M. Pharmacy/Pharm D