9.0 - 13.0 years

0 Lacs

karnataka

On-site

As the PV Operations & Safety Systems Lead in Pharmacovigilance at Biocon Biologics, you will be part of a pioneering company dedicated to revolutionizing healthcare. With a focus on patient-centricity, affordable innovation, and disruptive thinking, our goal is to impact a billion lives globally. At our multicultural organization, you will collaborate closely with partners and patients, working towards the shared vision of providing high-quality, affordable biosimilars to individuals worldwide. Reporting to the Head of Pharmacovigilance, your role will involve overseeing Pharmacovigilance operations and PV Systems functions within the Clinical Development and Medical Affairs department. Your primary responsibility will be to ensure compliance with regulatory requirements throughout the end-to-end Pharmacovigilance activities. Additionally, you will play a key role in establishing and maintaining PV safety systems in alignment with global regulatory standards. Your leadership will be crucial in managing the global pharmacovigilance system, including standard operating procedures and the Global Safety Database. You will interact with vendors, PV service providers, and business partners to facilitate PV data exchange and compliance. Your expertise will be instrumental in responding to safety information requests from regulatory authorities and participating in regulatory inspections, audits, and corrective actions as needed. In addition to overseeing outsourced PV activities, you will serve as a technical subject matter expert for both internal and external stakeholders. Strong communication, project management, and negotiation skills are essential for success in this role. Your qualifications should include a Bachelor's degree in pharmacy or a healthcare discipline, or a Master's degree in Life Sciences with extensive PV experience. With 12+ years of pharmacovigilance experience, including a minimum of 9 years in the field, you should possess a deep understanding of Good Pharmacovigilance Practices and relevant regulations. Based in Bangalore, India, this position offers the opportunity to lead impactful initiatives in a dynamic and fast-paced environment. If you are a motivated self-starter with a passion for innovation and a commitment to excellence in pharmacovigilance, we invite you to join our team at Biocon Biologics.,

Posted 3 days ago

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