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Company Description Roche Holding AG is a Swiss pharmaceutical and biotechnology company, recognized globally for its leadership in medical research, diagnostics, and the development of innovative medicines. Founded in 1896 and headquartered in Basel, Roche focuses on oncology, immunology, infectious diseases, ophthalmology, and neuroscience. With a strong commitment to personalized healthcare, the company integrates pharmaceutical and diagnostic solutions to improve patient outcomes. Roche operates subsidiaries in more than 100 countries and is known for its dedication to scientific innovation and sustainable development, offering professionals the opportunity to contribute to meaningful healthcare advances.
Role Description The Drug Safety Manager is a full-time, on-site role based in Tumakuru, responsible for overseeing the safety profile of Roche’s medicinal products throughout their lifecycle. This position manages the collection, assessment, and documentation of adverse event reports from clinical trials and post-marketing settings, ensuring timely and compliant safety reporting to regulatory authorities. The role involves leading signal detection and risk evaluation activities, collaborating closely with clinical, regulatory, and medical affairs teams to develop and update risk management plans and safety sections of product labels. The Drug Safety Manager implements and maintains pharmacovigilance systems and processes, supports safety-related audits and inspections, and provides guidance and training on drug safety standards to internal stakeholders. Day-to-day activities also include preparing safety summaries, contributing to safety strategy meetings, and continuously monitoring relevant literature and regulatory updates.
Qualifications
- Strong knowledge of Regulatory Requirements and experience in Regulatory Affairs related to pharmacovigilance and drug safety compliance.
- Background in Pharmacy or a related life science discipline, with the ability to interpret clinical and pharmacological data for safety assessments.
- Experience working with Clinical Trials, including safety data collection, adverse event reporting, and collaboration with clinical operations teams.
- Understanding of the Drug Development process, including pre-clinical, clinical, and post-marketing phases, and the evolving safety profile of products.
- Relevant degree (e.g., PharmD, MSc or equivalent) in Pharmacy, Pharmacology, Medicine, Life Sciences, or a related field.
- Proficiency in pharmacovigilance systems, safety databases, and standard office software; familiarity with international guidelines (ICH, EMA, FDA) is an advantage.
- Excellent analytical, problem-solving, and decision-making skills, with strong attention to detail and ability to manage multiple safety activities simultaneously.
- Effective written and verbal communication skills in English, with the ability to present complex safety information clearly to diverse stakeholders.
- Demonstrated ability
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