Assistant Manager

2 weeks ago

Ahmedabad, Gujarat, India Zydus Lifesciences Full time ₹ 6,00,000 - ₹ 18,00,000 per year

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.

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