Pharmacovigilance Specialist Job Opportunity at Dr. Reddy’s Laboratories Hyderabad

Purpose:

The PV Specialist is responsible to have oversight and management of SDEAs/PVAs for Business relationships in all regions. This includes coordination with various stakeholders, business relationship assessment, SDEAs/PVAs drafting, review & revision for Dr Reddy’s business relationships ensuring to meet the standard process and applicable regulatory requirements.

Responsibilities:

• To coordinate with various stakeholders involved in Business relationship of all regions to ensure:
• All main agreements are assessed for PV obligations to ensure either a PV clause or a separate SDEA/PVA is required and placed
• Existing SDEAs/PVAs are up to date with respect to the current templates with standard procedures and aligned with current legislation
• Ensuring that all key PV stakeholders are involved to support in drafting, review, approval and sign off of PVAs with necessary PV obligations based on Business terms, regulatory requirements and standard procedures.
• Lead the negotiation process with Business partner for all PVAs with support from Global PV Head, Head of PV Operations and Regional PV Heads as needed.
• Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder.
• PVAs Periodic revision: manage the process in set periodic cycle for review and update of existing PVAs to ensure all provisions are up to date with regulatory requirements and standard procedures.
• Periodically reviewing existing PVA templates to align with standard functional process and to design standard templates with the support and approval of Global PV Head and Head of PV Operations.
• Maintain comprehensive contracts Master list and Global PVA Exchange Matrix for all active PVAs and main contracts with PV clause to support the PV functional process implementation.
• Devise and maintain a process for ensuring the implementation of PVAs post- signing.
• Monitor ongoing compliance with terms and conditions of PVA and provide updates during internal compliance meetings. Ensure major non-compliance is escalated.
• Provide list of agreements to support generation of the PSMF when required
• Support PV due diligence activities for new product acquisitions/divestments as needed.
• Act as SME for PVA management during audit and regulatory authority inspections

Relationship Management

• Build relationship with key stakeholders – Regional PV Leads, Business Units and legal as applicable.
• Define practices under the supervision and support of Global PV Head and Head of PV Operations to implement the same.

Process Improvement / Standardization

• Ensure PVA templates keep pace with changes in legislation
• Identify areas of process improvement and propose recommendations
• Support process automation for PVA management, including establishing database reporting rules for distribution of ICSRs to partners
• Resolve issues related to PVAs with teams.

Desired Skills & Competencies

• Knowledge of global regulations including FDA, EU & emerging market guidelines.
• Understanding of PV operations to ensure appropriate negotiation of terms in all PVAs
• Demonstrate understanding of commercial agreements with a view to matching the required PV strategy to the commercial relationship
• Previous experience in PVA management
• Excellent teamwork and interpersonal skills
• Excellent time management and organisational skills