Senior Scientist, Pharmacovigilance Information Science

Job content

In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

The Pharmacovigilance service team is part of the Data Science group in pRED Data & Analytics located in Basel and has an active role in the Pharmacovigilance (PV) system at Roche.

Job mission

You are responsible for the global safety literature monitoring of all Roche drugs and supports functions including Drug Safety, Product Development Medical Affairs and Clinical Science in their activities related to ICSRs (Individual Case Safety Reports), signal assessment, aggregate safety reports to Health Authorities (Development Safety Update Report, DSUR), Periodic Benefit Risk Evaluation Report, PBRER) or safety queries from Regulatory Authorities.

Your impact

• Making sure that the Clinical Safety Scientists, Safety Operation, Global Medical or Scientific Directors (GMD/GSD) and Global Development Leaders (GDL) receive the relevant literature according to PV regulations

• Supporting affiliates in their local safety literature monitoring activities and interacting with other functions in PV.

• Nurturing trustful relationships and effective collaboration with internal and external partners

Your profile

You are a highly motivated, collaborative colleague with a good sense for priorities, flexibility and ability to work under short timelines when required. You will take responsibilities to perform professional literature searches on biomedical databases to identify published case reports of adverse drug reactions, safety signals or efficacy data of company’s medicinal products and you will manage a large number of automated literature searches (develop, document, quality check and maintain the search profiles).

You will run a quality management system to validate search profiles, write and review business relevant documents such as guidances, work instructions, specifications and reports. Work under Good Pharmacovigilance Practice (GvP) and participate in audits and Health Authority inspections as subject matter expert. Review and advance existing processes with novel technologies and develop improved workflows in close collaboration with customers and keep track of technical developments in PV landscape (automation, artificial intelligence, etc). You have an advanced degree in biology, pharmacy or medicine or equivalent education and work experience in life science, preferably in the pharmaceutical industry, experience in a drug safety or medical information science environment.

Our Commitment

Our commitment Roche commits to recognising talent and aptitude. We prioritize encouraging and supporting our employees in their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career. We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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