PHARMACOVIGILANCE QUALITY COORDINATOR HF

Job description

PAYS-BAS(Amsterdam)
du01 juin 2020au01 juin 2022(pour24mois)
ETABLISSEMENT :SANOFI-AVENTIS GROUPE
REMUNERATION MENSUELLE :2305€ (indemnité non contractuelle fixée par décret et arrêté, dont le montant peut varier notamment en
fonction de l’évolution du barème de référence, de la localisation de la mission et des cas d’abattements prévus par les textes)

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.

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.

We are looking for a candidate for a VIE mission of:

Pharmacovigilance Quality Coordinator - VIE Contract (W/M)

JOB RESPONSIBILITIES

- Providing quality inputs on tools, processes and activities in place in all regions to allow a consistent quality oversight of the Pharmacovigilance (PV) activities
- Contribute to deliver Quarterly Quality dashboards, providing oversight on country quality PV milestones
- Collect PV deviations across regions through diverse repository and tools
- Provide guidance to track and assess impact assessment of deviations at local level
- Contribute continuous improvement plan across countries for recurrent PV deviations/findings
- Support implementation of recommendations to enhance country PV systems in accordance with global processes
- Support on Rapid Quality Notification impacting country PV activities, ensuring timely resolution of CAPAs (Corrective and Preventive Actions)
- Support in the preparation of country office audits, definition of root-cause analysis and CAPA follow-up
- Provide analysis of PV findings trends across regions
- Support compliance of quality documents with local regulations and procedures
- Engage in development and implementation of training materials related to process improvement initiatives

REQUIREMENTS

- Pharmaceutical Degree or Master's Degree in Human Health Sciences
- Experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs / Quality Assurance
- Understanding of Pharmacovigilance regulatory requirements
- Experience in CAPA (Corrective and Preventive Actions) management
- Knowledge of MS office
- Able to work transversally
- Goal oriented
- Good interpersonal communication and networking skills
- Dependability, independent yet willing to incorporate feedback
- Ability to network with key stakeholders
- Organized and detail oriented
- Efficient at time management
- Analytic thinker
- Quick learner
- Pro-active
- Effective problem-solving skills
- Fluency in English verbal and written