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Assistant Manager/Deputy Manager-Pharmacovigilance

Assistant Manager/Deputy Manager-Pharmacovigilance

Hetero Labs Limited

8 - 10 years

0 Lacs

Hyderabad / Secunderabad, Telangana Telangana India

Posted:22 hours ago| Platform: Foundit logo

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Skills Required

PADER PSUR Pharmacovigilance PBRER

Work Mode

On-site

Job Type

Full Time

Job Description

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 andPBRERS/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