PV agreement

Job Description

• Operational support for the maintenance of PVAs
• Maintaining PVAs, including completing routine reviews, updating, project managing updates, and documenting
• Handling PV agreement/Clinical Trial CRO safety reporting agreement related activities
• Documentation to be maintained using Client templates and procedures and on the Client PVA Repository
• Medical/safety report writing or literature review and processing.
• Work on existing PV Agreement (license partner and distributor PVAs and CTSRPs or updates -simple, noncomplex)
• Work on PVA appendix update (covering territories and products)
• Work on PVA Contact List Update
• Work on Clinical Trial CRO Safety Reporting agreements (simple)
• Responsible for the development and ongoing maintenance of the Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) along with driving global and local implementation activities.
• End to end handling of all agreements such as Licensing Agreements (in-licensing and out-licensing), Product and Company Acquisitions/Divestments, all ranges from Clinical Collaborations, PSP, Safety management plans, RMP and new innovative partnerships as the contract landscape evolves
• Monitoring and maintaining the status update of all agreements and ongoing work in PVA database.
• Independently handing drawing, negotiating and finalizing new agreements, amendments and termination to existing agreements as per PVA standard SOP
• Supports the maintenance of the PVA database and retrieval of information from the PVA database