Manager - DSRM

Job Description

• Preparation and Maintenance of Pharmacovigilance System Master file (PSMF) for Global, and other regional markets as applicable, including preparation of detailed description of Pharmacovigilance System (DDPS), summary of PV systems etc.
• Management of PV system master file(s) and regular updates of associated annexures for PV system
• Manage PV matters for subsidiaries and affiliates across the globe including but not limited to integration of pharmacovigilance and drug safety between DSRM and subsidiaries, development and formation of SOPs and procedures.
• Perform KPI monitoring and compliance monitoring activities for subsidiaries and other countries where Lupin does not have subsidiary but operates through local partners.
• Ensure Pharmacovigilance due diligence in matters of mergers and acquisitions.
• Coordination with vendors, internal and external stakeholders relevant for various DSRM functions
• Actively contribute to the development of processes, applications and methodologies in the department including continuous process improvement

Education

Work Experience

Experienced candidate with 8 plus years of experience in relevant sphere of work which is subsidiary and affiliate management, along with experience of handling diverse PV system master files and global awareness on PV requirements across the globe.

Competencies