We are currently hiring a Country Safety Lead for our current Biogen entity in India.
As one of the first hires of this new set-up, the CSL, India, is the primary Pharmacovigilance (PV) point of contact for the local territory, fulfilling the regulatory mandated role of the Pharmacovigilance Officer in Charge (PVOIC)in India. The CSL is responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The CSL is a key strategic partner for the local business and provides valued consult and collaboration to all PV affiliate stakeholders and global functions to support local, regional and global PV objectives. The CSL also contributes to the Global and Regional PV strategy as required.

Responsibilities:
- Accountable for establishing and maintaining a local/regional PV structure and related practices in compliance with local Regulation and in synergy with Biogen’s Global PV system.




- Acts as the local/regional expert in all matters pertaining to PV within the post-marketing space and the aligned territory and provides strategic and operational consult to the local business. Contributes to PV matters in the Clinical space as required in collaboration with other Safety and Regulatory Operations, Medical Writing, and Benefit Risk Management (SABR) functions.
- Responsible for establishing optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensures procedures related to Local Literature Screening and ICSR Follow-up are in place.
- Where applicable, ensures Health Authority submission compliance of Aggregate Reports; maintains an up-to-date knowledge of local regulatory requirements for Aggregate Reporting and effectively communicates all related Regulatory intelligence to the International Pharmacovigilance (IPV) team and other SABR func

📌 Senior Manager Country Safety Lead (New Delhi)
🏢 Biogen
📍 New Delhi