Lallemand Pharma is a Swiss company based in Lugano dedicated to the production and marketing of medical device and pharmaceutical product.
We are looking for a Vigilance Manager at 50% able to take over the responsibilities of European Qualified Person for Pharmacovigilance (EU-QPPV) and manage, on behalf of the company, all activities related to the pharmaceutical and medical devices vigilance in compliance with all applicable regulations. Regulatory affairs support.
The person will report directly to the General Manger of the Company and will be responsible for the following main activities:
• To be responsible of all vigilance activities for pharma and MD products
• to coordinate with our partners any information that could have an impact on the pharmacovigilance/medical device vigilance activities including the management of the safety data exchange agreements (SDEA);
• To monitor and follow-up of the PSURs or RMPs and the PVSMF and its summary with the current external PV subcontractor, with the aim to integrate the externalized activities in the near future;
• To manage all Pharmacovigilance events related to our products in collaboration with the current external PV subcontractor, with the aim to integrate the externalized activities in the near future by evaluating, coding and declaring the events to the Authorities (management of all related database);
• To directly manage all the Medical device vigilance activities;
• Management of primary notification form, individual serious incidents and risks of incidents, Field Safety Corrective Actions (FSCA), explanatory statements, trend reports, periodic summary report, report on suspected serious incidents received from Health authorities, final reports, Field Safety Notice.
• Monitoring of pharmacovilance and medical device vigilance regulations, guidelines and literatures.
• Writing and updating of the standard operating procedures related to pharmacovigilance and medical device vigilance activities.
• To train the team for vigilance activities and be part of vigilance audit.
• To support regulatory affairs activities.
Degree in life sciences (biology, life sciences engineer, pharmacist) with 5 years’ experience in pharmacovigilance and medical device vigilance.
Person must be EU residence to bear the EU QPPV responsibility.
Computer skills (office pack).
Good knowledge of the pharmaceutical and medical devices vigilance regulations and guidances.
Knowledge of French will be preferential
Rigorous and autonomous
Good communication skills
Pro-active attitude and decision maker
Problem solving and attitude to work under tight schedule.
Please send your cv at firstname.lastname@example.org