Pharmacovigilence Team Lead/Manager(5 yrs Exp)

3 weeks ago

Pushkar, India Novaspire Biosciences Full time

Company Description Novaspire Biosciences is a trusted partner to the pharmaceutical, biotechnology, medical device, and nutraceutical industries, providing comprehensive and high-quality clinical research services. Our expertise spans the entire drug and product development lifecycle, from Phase I clinical studies to post-market surveillance. Core services include pharmacovigilance, clinical trial management, medical writing, bioequivalence study support, GxP consulting, and imaging studies. With over 75 years of combined experience, our team excels in ensuring compliance, optimizing processes, and delivering clean data to accelerate time-to-market. Novaspire is dedicated to improving patient safety and enhancing clinical trial outcomes with innovative and reliable solutions. Role Description This is a full-time on-site role located in Bengaluru for a Pharmacovigilance Team Lead/Manager with 5 years of experience. The role involves overseeing all pharmacovigilance operations, ensuring compliance with regulatory requirements, and managing adverse event reporting. Responsibilities include leading a team of pharmacovigilance professionals, developing and implementing risk management plans, coordinating with cross-functional teams, and contributing to regulatory submissions. The Team Lead/Manager will play a critical role in fostering a culture of patient safety and ensuring adherence to high-quality standards in all related processes. Qualifications - Strong understanding of Regulatory Requirements and experience in Regulatory Affairs - In-depth knowledge of pharmacy and medicine principles relevant to pharmacovigilance and drug safety - Experience with Clinical Trials, including post-market surveillance and risk management - Demonstrated leadership, team management, and excellent communication skills - Proficiency with pharmacovigilance databases and tools - Master’s or postgraduate degree in Pharmacy, Medicine, Life Sciences, or a related field - Knowledge of local and international regulatory guidelines, such as ICH-GCP, is highly desirable - Attention to detail, problem-solving mindset, and the ability to work effectively under timelines

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