Assistant Manager - Pharmacovigilance Compliance Team Zydus Lifesciences

4.0 - 8.0 years

6 - 10 Lacs

ahmedabad

Work from Office

Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate Preparation, review, and maintenance of safety data exchange agreement/pharmacovigilance agreement/any other agreement. Management of the Quality document (SOPs/Policy/Conventions) planning and their compliance. Training management and documentation Ensuring the third parties (Business partners and vendors) qualifications and its documentation Collaborating with key stakeholders to ensure metrics meet oversight needs Coordinate with vendor for activities like Computer system Validation, User Management, Database Training, WHODD, MedDRA Version update, etc Continuous Monitoring of Regulatory Requirements (Surveillance) Management of Company Product Dictionary Handling archival and retrieval activities of pharmacovigilance-related documents Preferred candidate profile Candidate must have minimum 3 years experience in PV-Compliance. Candidate must have relevant knowledge of all PV areas like ICSR, aggregate reports, medical writing etc.. Candidate must be ready to work in office.

Posted 22 hours ago

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