Pharmacovigilance associate
Puteaux, FR
Job Purpose
Corporate Pharmacovigilance Associate in the safety profile evaluation group / charge de pharmacovigilance surveillance du profil de securité
be the subject matter expert for safety for the assigned product in a international environment and be the SME for one process such as PBRER/ and or RMP ( to be defined)
Key Responsibilities
-The pharmacovigilance associate is responsible for the assigned products with the support of a vendor
-medical assessement at case level
- literature review
-signal detection activities ( detection, assessement, action takens ) / monitoring the implementation of CCDS change in the local product information
- Safety analysis authoring
- Answer to health authority questions during registration renewal...
- PBRER strategy coordinate the authoring
- RMP with associated risk minimization activities
- ensure process update with corresponding procedure for the assigned process
- participate to inspection and audits
Required Education
Pharm D, Physician, Scientific profile
Master in pharmacovigilance or strong PV experience in the safety assessment profile
> 2 years experience required in similar position
Required Skills and Experience
organized, rigorus, accountable, committed,proactivity, synthetic mindset
Technical Competencies
critical thinking,
case analysis synthesis and case assessement
medical writing skills
project management
Safety profile regulations and guidance knowledge
#LI-KL1
Required Behaviours and Competencies
accountability
focus on the target
team spirit
creative and proactivity
flexible
Required Languages
fluent in english.
Travel required in %
very few