Medical Review and Reporter Follow up - VIE Contract

Medical Review and Reporter Follow up - VIE Contract

• Location: Germany, Frankfurt
• Target start date: 01/07/2024

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address. 

About the job

Pharmacovigilance is concerned with the safety of patients when they use our medicines. You will be primarily responsible for tracking the side effects of our medicines. In addition, you could be involved in the approval of new projects such as market research studies especially for new products and, depending on the extent of their competence, also take on other pharmacovigilance tasks such as organizing and participating in RMP team meetings (risk management team meetings), launch team meetings etc. As Medical Review and Reporter Follow up in our Pharmacovigilance team, you’ll gain an insight into a field that is largely unknown to them – pharmacovigilance.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Cooperation in the proper research of individual suspected cases on drug risks, taking into account all possible sources (e.g. physicians, pharmacists, patients, authorities). Medical follow-up of these suspected cases with the reporters or other participating physicians via e-mails, letters and phone calls.
• Cooperation in the evaluation of the received reports according to the national and international standards within the framework of the Sentinel function/Signal detection. Consideration of medical/clinical differential diagnostic aspects and knowledge of the modes of action of the medicinal products used in this patient, the clinical picture and clinical-pharmacological aspects, e.g. regarding Interactions.
• Cooperation in the detection of risks/signals resulting from individual case reports or the sum of reports on a product. From this, if necessary medical development of measures for the protection of patients with the use of medicinal products and risk minimization in cooperation with a physician or pharmacist.
• Cooperation in the implementation of risk-minimizing measures (aRMM) for risk prevention: (e. g. organizing RMP (Risk Management Plan) meetings, preparing RMP meeting minutes and filing aRMM documents in Sharepoint).
• Cooperation with the medical drug information regarding Safety aspects and instructions for use for the therapy (e.g. adaptation of SmPC and PIL) for physicians, pharmacists and patients.
• Together with a physician or pharmacist, cooperation in the study safety management of studies: Phase III to IV studies, but also observational studies and other non-interventional studies, investigator sponsored studies as well as market research programs. Safety management includes among other things the responsibility for implementing the safety processes involving vendors as well as reviewing the safety chapter of the protocol and creating the safety chapter of the study report, considering Sanofi standards.
• Cooperation with Vendor management (CPOC, Department of our external Vendor Parexel), and among other things maintenance of German Annexes to the global job aids, communication with the vendor
• Continuous feedback to optimize the design of area-specific work processes.

About you

Experience:

• Licensed pharmacist or physician.
• Experience in Pharmacovigilance/Drug Safety.

Soft and Technical skills:

• Good in medical knowledge and language.
• Data management and analysis skills.
• Strong organizational skills, discipline in daily activity planning and prioritizing.
• A positive can-do attitude, passion for work and technology, attention to detail, and the ability to thrive in a highly interactive, fast-paced, team environment.
• Excellent written and oral communication skills.
• Proficiency in relevant pharmacovigilance databases and software, as well as Microsoft Office applications. Experience with Sharepoint for document management is a plus.

Education:

• PharmD, Doctor of Medicine, or equivalents.

Languages:

• Fluent English and German are mandatory (written and spoken).

Why choose us?
iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.