Medical Safety Lead

Benefits

Additional Information

Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams. Job Description Major accountabilities: Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately . Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on products. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Contributes to the development of departmental goals and objectives. Distribution of marketing samples (where applicable) Minimum Expectation: Medical/scientific related degree Must have 8+ years of experience in medical review in Drug safety /pharmacovigilance. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! Skills Desired Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science