Head Pharmacovigilance India Abbott Laboratories

10.0 - 14.0 years

0 Lacs

maharashtra

On-site

The Affiliate Safety Representative (ASR) in India plays a crucial role in ensuring that all activities related to pharmacovigilance (PV) for Abbott EPD investigational and registered medicinal products under Abbott India Limited (AIL) and Abbott Healthcare Pvt Ltd (AHPL) are conducted in compliance with internal Abbott policies, procedures, and local regulatory requirements. The ASR is also responsible for overseeing PV activities in neighboring countries such as Nepal, Bhutan, Maldives, and Sri Lanka. Additionally, the ASR serves as the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization. Key responsibilities of the ASR include: - Acting as the Pharmacovigilance Officer In-Charge (PvOI) on a 24/7/365 basis - Maintaining the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates - Conducting PV business continuity planning and notifying any business interruptions that may impact pharmacovigilance processes or regulatory compliance - Receiving, recording, and reconciling safety information - Conducting safety surveillance, including literature and health authority website screening, and preparing local periodic safety reports and Risk Management Plans - Submitting safety information to regulatory authorities - Providing basic PV training to local EPD staff - Managing PV records retention and archiving - Implementing out-of-office coverage for receiving and recording safety-relevant information - Maintaining the local PV product list - Ensuring PV compliance in local interventional studies and data collection schemes - Negotiating and implementing local pharmacovigilance agreements - Conducting due diligence for product acquisition or in-licensing - Providing local PV Compliance metrics and managing non-compliances - Coordinating PV audits and inspections at the Affiliate level - Ensuring vigilance compliance for various Abbott EPD products - Supporting in the preparation of Health Hazard Assessment/Medical Expert Statements - Acting as a Marshal for PV Self-Assessment Work Instruction and PV Representative for Global Clinical Programs - Reviewing and approving local PV training matrices - Collaborating with stakeholders to exchange PV-relevant information - Handling global projects The ASR is responsible for managing a team of direct reports and is accountable for the implementation and maintenance of a functional and compliant local PV system. The role requires expertise in PV, understanding of local PV regulations, attention to detail, computer literacy, strong English language skills, and effective communication and presentation abilities. Minimum qualifications for the role include: - 10+ years of PV experience in a pharmaceutical company - Understanding of local PV regulations - Attention to detail - Computer literacy (Windows, MS Office) - Good English language skills - Strong communication and presentation skills with internal and external stakeholders Ideally, candidates should hold a graduate degree in Medicine, Pharmacy, or equivalent qualification.,

Posted 1 week ago

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