Pharmacovigilance Associate - Data Surveillance

Pharmacovigilance Associate - Data Surveillance

Galderma

Uppsala, Sweden

Job description:

• You will implement Pharmacovigilance plans, processes and policies related to the collection, assessment and prevention of adverse effects following the use of our marketed or development products and ensuring the quality of PV activities in R&D projects in accordance with GxP, local and international regulations and guidelines;
• You will manage regular adverse event case management activities and be responsible for the preparation of safety-related reports for regulatory submissions;
• The position is primarily focused on our Medical Device products but will also include similar tasks for Medicinal products within our portfolio.

Key responsibilities:

• Implement adverse event management and reporting processes;
• Reconcile and process high-quality product safety data to internal and external stakeholders throughout the product life cycle;
• Ensure training and oversight of external service providers for adverse event processing activities and perform quality control activities to ensure data consistency;
• Align and implement Pharmacovigilance plans and activities to provide integrated strategic safety expertise and safety deliverables to clinical development programs;
• Prepare department quality documents and participate in quality audits and inspections;
• Contribute to implementation and maintenance of the global safety database.

Skills & Qualifications:

• Master’s or Bachelors’ degree in Life Sciences or equivalent;
• Minimum of 2 years’ experience in Pharmacovigilance;
• Good knowledge of ICSR management in a safety system environment and of AE and drug coding conventions (MedDRA, WHO-DD) from the pharmaceutical/medical device industry;
• Fluent in English written and oral.

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