Head of Country Pharmacovigilance (Detta uppdrag är avslutat)

maj 12, 2013

Scientific Solutions specialises in talent supply for Life Science companies. We focus on management and specialist roles mainly within R&D, Clinical, Regulatory, Drug Safety, Sales and Marketing.

We are now looking for a experienced pharmacovigilance professional for an exciting position as Head of Country Pharmacovigilance (PV). This is a temporary position (consultancy assignment) for 6 months. The position is located in the Netherlands.

Summary
As the Head of Country PV, you report directly to the Country Medical Director. You will, in close liaison with all appropriate functional groups, locally and globally, manage all product safety related issues that arise in the country. Furthermore you will lead cross-functional teams to ensure that internal and external inspections are conducted effectively, and act as the local PV representative where appropriate.

Main responsibilities

Collect, follow-up and forward single adverse event reports originating from the local market.
Ensure the timely and appropriate submission of local and foreign adverse event reports to the local per the local regulatory reporting requirements.
Act as a point of contact for the local Health Authority (HA) and Ethics Committees (ECs) for PV related issues, and for PV enquiries from local office employees. Manage requests from the local HA regarding PV issues, in close liaison with appropriate functional groups, e.g. Medical Affairs, Regulatory and Marketing.
Provide PV training to non-PV personnel and inputs into the development of PV training materials, as appropriate.
Ensure inspection readiness, facilitate and participate in PV audits and inspections.
Maintain an oversight of the local market plans of aggregate reports submissions (planning and tracking submissions in the global safety database) and ensure timely submission to the HA and ECs as per the local regulatory reporting requirements.
Perform and document reconciliation with Medical Information enquires.

Required Qualifications

Medical, pharmacy or life science degree.
At least 5 years of experience within the pharmaceutical industry, usually with at least 2 years in PV.
Comprehensive knowledge of drug development and commercialization processes, and related business implications.
Comprehensive knowledge of local and regional PV legislation, ICH guidance and the obligations on pharmaceutical companies to HAs, health professionals and patients.
Excellent verbal and written communication skills (both in English and in Dutch). Ability to apply principles of effective communication and to impact and influence people.

Desirable personal characteristics

Thorough, structured and have strong organisational skills
Service-minded approach
Ability to handle several tasks simultaneously

To succeed in this role you must have excellent communication skills, ability to pursue issues and to structure your own work. Furthermore should you also have excellent leadership abilities and be passionate about pharmacovigilance.

To apply for this position, send your CV and a short personal letter to [email protected].
Apply as soon as possible, no later than May 24.
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.