We are looking for a Senior PV Officer / (Deputy) QPPV

Interdos Pharma BV is a pharmaceutical company as well as an independent CRO providing services for human medicinal products and medical devices (CE products).

The clients of Interdos Pharma BV are mainly small and medium-size pharmaceutical companies worldwide, who often have a pharmacovigilance (PV) system under development or are undergoing major changes with (initial) marketing authorization applications.

The team of Interdos possesses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory support, PV services and quality assurance activities.

To strengthen the PV department, we are looking for an experienced professional to join our company as Senior PV Officer / Qualified Person responsible for Pharmacovigilance (QPPV) to ensure complete oversight of the PV systems of Interdos Pharma BV and his business partners.

Core duties include:

• Being responsible for the establishment and maintenance of the PV system of Interdos Pharma BV as well as the PV systems of the other marketing authorization holders as laid down in Directive 2001/83/EC and the Guideline on Good Pharmacovigilance Practices (GVP);
• Ensuring 24h/7d availability for the safety of medicinal products;
• Keeping overview of medicinal product safety profiles and emerging safety concerns;
• Ensuring and verifying that the information contained in the PSMFs of the marketing authorization holders are accurate and up to date reflecting the PV systems under the QPPV’s responsibility;
• Performing QPPV function within the company and globally, ensuring constant compliance with European PV Legislation and European Regulations;
• Ensuring awareness of compliance with PV requirements. This includes, but is not limited to individual case reports, aggregate reports quality, submission timeliness, and implementation of risk minimization activities;
• Participating in signal management activities and contributing to identification and evaluation of safety signals from all available sources;
• Being accountable for continuous pharmacovigilance evaluation of authorised medicinal products of the companies;
• Working with safety data exchange agreements (SDEAs) and ensuring timely update of the contracts;
• Awareness of any conditions or obligations adopted as part of marketing authorizations and other commitments relating to safety or safe use of products;
• Being involved in development and review of PSURs, RMPs, addendums to the (non)clinical overview and other scientific documents and including risk minimization measures;
• Building strong working relationships with Local Safety Officers.

Knowledge/expertise:

• Pharmacovigilance experience with the strong ambition to become QPPV or already eligible to act as a Qualified Person for Pharmacovigilance under EC/2001/83 Directive;
• Academic (Pharmaceutical) master degree in life sciences (WO);
• Solid knowledge of international pharmacovigilance regulations and guidelines;
• At least 5-10 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organization;
• Previous experience as EU QPPV (or Deputy) preferred;
• Analytical, solution orientated and dynamic approach.

What we offer:

• A very challenging work environment in a highly qualified team;
• Opportunities for growth and personal development;
• Competitive compensation with good secondary employment conditions.

Acquisition in response to this vacancy is not appreciated.