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Senior Specialist- Drug Safety (Literature Safety Surveillance)
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- As Senior Drug Safety Associate for the Literature Safety Surveillance process you join our Safety Operations team in the Research & Development Excellence Center Bangalore.
- Your key responsibilities are
- To support of the business process owner for the literature surveillance process
- Main point of contact for local non-ICSR references including manual upload to safety literature database
- Training documentation and user access management in the literature surveillance database
- Operational management activities in the literature safety database such as reconciliation, QC of non-ICSR literature
- Ensure the distribution and filing of updated reference safety information within GPS Operations
Who you are:
- You have a medical/scientific degree and at least 3 years of experience in the pharmacovigilance environment - ideally, you have worked in the literature safety surveillance process before.
- You have a sound understanding of regulations relevant to the safety of drugs in development and post-authorization.
- Good communication skills and experience in an international environment are equally important as intercultural experience through successful collaboration in matrix teams.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!