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Head of PV, Med Info & Compliance
Are you up for a challenge?
Do you enjoy working in a positive team of talented and inspiring colleagues, and are you keen to work in the Pharmaceutical industry?
For the Human Pharma Business Unit of one of our clients, we are looking for an autonomous, experienced and proactive Head of Pharmacovigilance, Med Info & HealthCare Compliance. In this role you will be responsible for ensuring the establishment and maintenance of a local pharmacovigilance system and you will act as local PV point of contact person (local QPPV) for the national health authority.
Additionally, you are the compliance expert who will ensure the implementation and maintenance of global, regional and local policies, procedures and processes related to Healthcare Compliance.
This is an office-based role in Brussels, and you will report to the Medical Director.
- Ensure the development, implementation and continuous improvement of the compliance Program regarding HCC and manage the information received locally (PV, Med info and HCC);
- Ensure implementation of activities (e.g. training) to enhance PV, Med info and HCC compliance culture;
- Maintains appropriate PV/HCC/Med. Info knowledge to ensure that the company fully complies with PV & HCC-relevant regulations. Proactively cooperates with PV intelligence, GPV operations and other line functions such as regulatory affairs on any upcoming new regulations to assess the local impact and their implementation;
- Contributes to benefit-risk assessment of product portfolio;
- Acts as the key expert for any PV-relevant topics and ensures proactive communication as appropriate;
- Regularly updates the local leadership team about the performance of the local PV and HCC system/program and proactively escalates any issue;
- Ensures appropriate PV, Med info and HCC training of all staff and those working on behalf of;
- Install/Maintain adequate and clear local contracting, promotional material review processes and monitoring;
- Manages local Pharmacovigilance Agreements in cooperation with global partner management;
- Contributes to the PV Quality system / HCC system in:
- Ensuring that the PC local working instructions and the local PV system repository correctly describe the local PV system and reflect global PV-relevant processes as well as specific local requirements;
- Ensuring local PV inspection readiness and participation in PV audits and local PV inspections;
- Cooperating with GPV compliance in identification of PV and PV-relevant non-compliances(NCs) occurring during routine business and timely CAPA development;
- Ensuring that an up-to-date PV business contingency plan is in place;
- Ensuring solid management of HCC incidents and CAPA management reporting is in place;
- Ensures screening of the scientific literature for identification of PV relevant information;
- Ensure close collaboration with business functions to understand the business partners’ needs and helping them anticipate on changes in the regulatory environment.
Skills and personality
- A degree as MD, Pharmacist, PhD or Masters Degree in a scientific or health care discipline;
- At least 3 yearsof leadership/management experience for LPVM and healthcare compliance with line-management of a PV and/or HCC team, registered LRMI is a plus. You are able to empower and engage your team and you show agility and flexibility to deal with complex situations;
- Excellent knowledge of relevant pharmacovigilance and healthcare compliance regulations and GCP, technical knowledge of drug safety databases regarding submissions and safety information exchanges;
- Excellent command of the English, Dutch and Frenchlanguage (advanced level is required);
- Strong leadership and communication skillswith or without direct line-management responsibility, ability to prioritize in a complex and rapidly changing environment;
- Accountable: prioritize your work, and drive execution excellence through discipline and collaboration;
- Project management skills, ability to influence in a matrix organization, ethical role model, business acumen;
- Results oriented, dynamic and agile.
+- 10 years
Dutch, English, French
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