Senior Role - Drug Safety/Pharmacovigilance/Medical Writing

- Job opening for Managing Pharma-operations/ Pharma co-vigilance operations role at a leadership level with one of the renowned BPO/ ITES.

- End to end Pv Operations role with Medical Writing exp, Literature search etc.

- Team management exp is mandate, End to end Responsibilities of Service delivery.

Location - Pune

Minimum Experience - 14+ yrs

Communication skills should be excellent.

- Domain Lead for acquiring critical business deals, establishing onsite R&D relationships and transitioning of systems & processes for Medical Writing and Medical Affairs at TCS for global pharma companies

- Create and prepare the business plan and propose the investments for establishing the Medical Writing Center of Excellence and grow the account

- Establish Medical Writing services across the sectors- Pharma, Medical Devices and Consumer Health care

- Develop Medical Devices- CER and CEP capabilities to be in compliance with EU-MDR requirements

- Establish Medical Affairs capabilities- focusing on content creation and Medical Review for the top global pharma companies

- Create the industry standard competency development plan, do the gap analysis and train the resources to enhance their competency levels

- Identify the new capabilities within the existing account and ensure growth within the account

- Develop sourcing solutions, respond to RFI/RFPs, transition processes from client sites to offshore locations in India, Set-up of the operations, team building and knowledge transfer for various Medical Writing opportunities

- Provide domain expertise and support development of automation solutions for End to End Medical Writing services

- Part of Academic Interface Program team - collaboration with the pharma colleges and provide training to the students. The aim is to bridge the gap between the industry and academia and develop the industry-ready talent pool.

Providing services for end to end Pharmacovigilance activities and Medical Writing services. Leading a team of over 150 resources, responsible for delivery of agreed services with client partner aligned with regulatory requirements.

Key responsibilities : Operational, Financial planning, performance, Profit/Loss of project/s,Process Improvement-Efficiency, Quality, Compliance and Innovation, Talent management, Client relationship, identify and support opportunities for revenue generation to drive sales growth and capability. Additionally, provide strategic inputs to Senior Leadership to improve client relationship, inputs for strategic planning for operational activities.