Assistant Manager/Deputy Manager-Pharmacovigilance Hetero Labs Limited

8.0 - 10.0 years

0 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

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

Posted 1 month ago

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Executive/Senior Executive Pharmacovigilance- Hyderabad Hetero

3.0 - 6.0 years

1 - 6 Lacs

Hyderabad

Work from Office

Role & responsibilities To prepare and 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. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective communication with country-specific pharmacovigilance contacts to support global reporting obligations. Support internal and external audits by providing accurate and timely safety documentation and regulatory compliance records. Interested Candidates please send me resumes to sravana.a@hetero.com

Posted 1 month ago

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