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Medical Review and Reporter Follow up - VIE Contract (W/M/D)

DATE PUBLIÉE 05/16/2024
type de contrat Full time
reférence de l’emploi R2724346
location Francfort-sur-le-Main, Allemagne

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.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission:

Medical Review and Reporter Follow up - VIE Contract (W/M/D)

Target start date: 01/07/2024

We are looking for a licensed pharmacist or physician to provide temporary support with the market launch of e. g. a new medicinal product, ideally with existing experience in the field of pharmacovigilance.

Very good written and spoken German and a willingness to work in a team are essential for these activities.

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, taking into account 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.


Key “MUST HAVE” competencies, skills & experiences:

Education:

  • PharmD, Doctor of Medicine, or equivalents.

Languages:

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

Experience:

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

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.

Pursue progress. Discover extraordinary.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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  • Contingent Worker, Francfort-sur-le-Main, Hesse, Allemagneretirer