DGM-Pharmacovigilance

Job Description:

Responsibilities

• Head the Safety Evaluation And Risk Management Team
• Author/review/approve safety reports and maintain oversight
• Contribute to the development and implementation of Risk Management Plans including authoring/review/approval
• Review and oversight of Signal detection and evaluation activities
• Liaise and collaborate with other GPV functions, Global Glenmark affiliates and external business partners
• Review draft responses to regulatory authority/healthcare professionals queries as applicable
• Review literature search results for ICSRs and articles for inclusion in safety reports
• Participate in governance meetings
• Support product labelling activities
• Support audits, inspection and CAPA management relating to SERM activities
• Support assessment and implementation of regulatory intelligence impacting SERM activities
• Provide technical guidance in the development and maintenance of procedural documentation
• Support organizational initiatives in driving global operational excellence in Pharmacovigilance
• Support the QPPVs

Qualification & Experience

• MD/MBBS
• Years of experience: 16-18 years