Pharmacovigilance Operations Officer
That's XPE. For one of our clients we are looking for: Pharmacovigilance Operations Officer Organisation description:
Our client, a global company providing high-quality healthcare pharmaceuticals and nutritionals, is hiring a Pharmacovigilance Operations Officer - Affiliate Liaison within their Global Safety Surveillance Department.Job description:
AGREEMENTS Establish and maintain productive alliance relationships with all key internal and external stakeholders in the review and implementation of Pharmacovigilance Agreements/Safety Data Exchange Agreements. Develop and maintain appropriate Pharmacovigilance Agreements/Safety Data Exchange Agreements for the organization with close collaboration with affiliates, business partners, vendors, Global Drug Safety, Global Regulatory Affairs and Global Quality Assurance. Participate in due diligence matters. Facilitate/Lead agreement negotiation meetings. Build safety agreement templates that are current with PV regulations and oversee their regular review and revision. Contribute to department initiatives (SOP review, process improvements). Develop KPIs and metrics for PhV partner and vendor agreements. Assist with the monitoring of PhV partner compliance to SDEA. Assist with process, tools and tracking mechanism for departmental deviations relevant to the SDEA Collaborate with management to achieve the objectives of the Department. Perform ad hoc duties & projects as assigned. LIAISON WITH AFFILIATES This role is instrumental in linking local PV activities to the central corporate PV You are responsible for effective communications processes and strong governance of local PV processes and their implementation/compliance at a regional/local level Coordinate the development and maintenance of the company pharmacovigilance network Support the EEA QPPV oversight, awareness and issues resolutions. Organize a quarterly affiliate safety meetings (TC) Support local PV initiated projects with Local PV contacts Coordinate PhV questionnaire with affiliates in relation to medicinal products and local PhV activities ensuring appropriate questions developed for the relevant PhV purposeProfile:
Life science degree (pharmacy, medicine, …) or equivalent through experience. You have at least 2 years of significant and successful experience in international Pharmacovigilance with knowledge in Safety Data Exchange Agreements with Affiliates, vendors and business partners and liaison with Affiliates Highly analytical, process minded and detail oriented. Be able to work in a matrix environment whilst remaining organized at all times. You demonstrate initiative and capacity to work under pressure. You have a hands on-mentality and a proactive attitude. Your are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset. You are a true team player and demonstrate leadership within cross-functional team environment.Offer:
You are offered a full time permanent contract with the possibility after to be engaged permanently by the client. You gain experience in a global, fast growing business and within a collaborative and entrepreneurial working environment where employees can be proud of the meaningful work they do!
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713