PV Agreement Specialist

1 week ago

Mumbai Metropolitan Region, India Tata Consultancy Services Full time

TCS is hiring for PVA - PV Agreement Specialist Role


Role: PV Agreement Specialist

Work location: Mumbai/ Pune/ Chennai/ Indore/ Hyderabad

Experience: 3 - 10 years’ relevant experience in PV Agreement Drafting

Qualification: Any Life Science Graduates


Job Description:


The jobholder will be responsible for the development and ongoing maintenance of Pharmacovigilance Agreements (PVAs) and will ensure the most recent versions of agreements are stored within the PV Database .

This will be for any contractual arrangement between the company and its partners per appropriate tools, procedures and systems.


Examples of contractual arrangements are all types of Licensing agreements, product and company acquisitions, all ranges from clinical collaborations, safety management plans and any new innovative partnerships as the contract landscape evolves.


The jobholder is the liaison between company and the Partner, functional PV System stakeholders and will lead the negotiations of the agreement ensuring mutual understanding, liaising appropriately with internal stakeholders and in close partnership and alignment with respective global and business process owners.

The jobholder is accountable for Independently drafting, negotiating, and finalizing new agreements, and amendments to existing agreements, as per Pharmacovigilance Agreement (PVA) standard operating procedures. This will include the following activities –


▪ Drafting the agreement based upon approved PVA templates

▪ Co-ordinating input into agreements from concerned parties

▪ Compiling agreements

▪ Determining Companies’ position and negotiating terms of agreement with third parties

▪ Co-ordinating review cycles and sign-offs

▪ Implementing agreements

▪ Managing Safety Data Exchange Agreement (SDEA) queries


The job holder will be expected to:

● Adopt and champion agile methodologies to drive efficiency, promoting creative/ adaptive teamwork approaches in problem-solving & lean development approaches

● Be an active member of the PV Partnering team, collaborating across the organization to ensure a non-siloed approach and apply systems thinking mindset


Experience, Skills, Knowledge:

● Thorough experience in areas relevant to pharmacovigilance system (~ 5 years)

● Thorough experience in end-to-end safety agreement management

● Vast experience in business partner management; sound understanding of contractual set ups requiring safety agreements

● Expert knowledge of PV system and GVP/GCP regulations and guidelines



Thanks & Regards,

Apeksha Bhosale

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