Pharmacovigilance Associate

Pharmacovigilance Associate

Recordati

Puteaux, France

Key Responsibilities

• The pharmacovigilance associate is responsible for the assigned products with the support of a vendor
• medical assessment at case level
• literature review
• signal detection activities (detection, assessment, action taken )/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, rigorous, accountable, committed, proactivity, synthetic mindset

Technical Competencies

• critical thinking,
• case analysis synthesis and case assessment
• medical writing skills
• project management
• Safety profile regulations and guidance knowledge

Required Languages

• fluent in English

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