PHARMACOVIGILANCE - MANAGER / Sr. MANAGER

Hetero

0 - 1 years

8 - 13 Lacs

Hyderabad

Posted:1 day ago| Platform:

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Skills Required

medical writing solar energy pharmaceutical team management ich-gcp guidelines pv drug safety clinical data management solar pharmacovigilance ich renewable energy psur case processing clinical research compliance argus meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance.
Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures.
Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission
To develop and review pharmacovigilance SOPs.
Coordination with MICC for ICSR activities and regulatory compliance.
Coordinating the safety data exchange agreements between Hetero and business partners.
Responsible for providing guidance and training to team as and when required.
Responsible for identifying, implementation and continuous improvement activities.
Responsible to handle audits and inspections

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