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PV Manager

2 weeks ago


Hyderabad Secunderabad Telangana, India beBeePharmaceutical Full time US$ 90,000 - US$ 1,20,000

The role of PV Specialist-Safety Data Exchange Agreements involves overseeing and managing agreements for business relationships across all regions. This includes coordinating with various stakeholders, conducting business relationship assessments, drafting, reviewing, and revising agreements to meet standard processes and regulatory requirements.

Responsibilities:

  • To coordinate with multiple stakeholders involved in business relationships across regions to ensure that:
  • All main agreements are assessed for PV obligations to guarantee either a PV clause or a separate SDEA/PVA is included
  • Existing SDEAs/PVAs are up-to-date regarding current templates, standard procedures, and aligned legislation
  • Ensure key PV stakeholders are involved in supporting the drafting, review, approval, and sign-off of PVAs with necessary PV obligations based on business terms, regulatory requirements, and standard procedures
  • Lead negotiations with business partners for all PVAs, supported by Global PV Head, Head of PV Operations, and Regional PV Heads as needed
  • Track and file executed PVAs and main agreements within the global comprehensive tracker and dedicated share folder
  • PVAs Periodic revision: manage the process in set periodic cycles for reviewing and updating existing PVAs to ensure all provisions align with regulatory requirements and standard procedures
  • Periodically review existing PVA templates to align with standard functional processes and design standard templates with the support and approval of Global PV Head and Head of PV Operations
  • Maintain a comprehensive contracts Master list and Global PVA Exchange Matrix for all active PVAs and main contracts with PV clauses to support the PV functional process implementation
  • Develop and maintain a process to ensure the implementation of PVAs post-signing
  • Monitor ongoing compliance with terms and conditions of PVAs and provide updates during internal compliance meetings. Escalate major non-compliance issues
  • Provide lists of agreements to support generating the PSMF when required
  • Support PV due diligence activities for new product acquisitions/divestments as needed
  • Act as an SME for PVA management during audits and regulatory authority inspections

Relationship Management

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

Process Improvement / Standardization

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

Required Skills & Qualifications

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 organizational skills