Pharmacovigilance Officer - VIE Contract (W/M)

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

PLEASE NOTEthat 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.

Market/ Environmental observation

• As a project collaborator, gather information about the trends, requirements, objectives and strategies of the department, the other departments of the subsidiary, the group and the market in order to participate to the good efficiency of the department

• Follow pharmacovigilance (PV) objectives, strategies and requirements

• Keep up-to-date on knowledge and monitoring of national and international PV regulations

Development of strategy/work plan

• Set priorities according to legal obligations and deadlines

• Find the most effective way to achieve the objectives with the means available

Implementation of Strategy/work plan

• Write reports in accordance with the GPV

• Coordinate and process PV alerts in collaboration with GPV and Local Management;

• Ensure that all local security data is centralized

• Ensure proper archiving at all times to keep documents related to security information accessible

• Contribute to the redaction and the transmission of the monthly PV report to the GPV

• Write standard operating procedures (SOPs) related to PV

• Provide PV training for new collaborators / subcontractors

As a supervisor of the safety aspects of Sanofi, ensure that the reporting of side effects to the Authorities is complete, accurate and transmitted on time.
• Ensure that PV cases are reported on time to relevant competent authorities and ensures that they are detected.

• Check and approve study documents

• Monitoring patient support programs, market research, social media, safety data exchange agreements, risk minimization measures, periodic safety reports

Ensure the support of the Country Safety Head (CSH) in the accomplishment of her tasks and missions

Key “MUST HAVE” competencies, skills & experience

Education:
Master’s degree in Medical / Scientific area

• Knowledge of epidemiology would be a plus

IT skills:

MS Office: proficient level (advanced Excel knowledge)

Language(s):
Fluent English and at least one of the two national languages (Dutch or French)

Other desirable skills:

• Presentation techniques

• Teaching skills

• Working accurately and scrupulously, in a structured way and with autonomy

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.