Assistant Manager - Pharmacovigilance Compliance Team

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.