PV Operations Officer - Global Safety Data Exchange Agreements - Overs
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PV Operations Officer - Global Safety Data Exchange Agreements
Location - Belgium
The company is headquartered in Belgium (near Ghent). In order to support the Director, Head of global Safety Surveillance and the EEA QPPV in establishing relationships with all key internal and external stakeholders for partnerships and to strengthen the Global Safety Surveillance group, we are currently looking for a PV Operations specialist (SDEA/Affiliate liaison) (m/f).
This position provides development and oversight of the Safety Data Exchange Agreements for the.This individual develops a working relationship with business partners, vendors and affiliates and fosters a culture of continuous improvement and identifies opportunities to further enhance quality and compliance with them. Lead development, review and implementation of Safety Data Exchange Agreements including activities associated with these agreements. Assists Sr.PV Operations Officer (PV/QA, Compliance, Training) with implementation of compliance relevant activities with business partners, vendors and affiliates. Acts as a liaison in negotiations with affiliates, vendors and business partners.
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. Lead PhV discussions during audits Audits and Inspections relating to safety agreements. Perform ad hoc duties as assigned.
LIAISON WITH AFFILIATES
This role is instrumental in linking local PV activities to the central corporate PV You will be responsible for effective communications processes and strong governance of local PV processes and their implementation/compliance at a regional/local level You will coordinate the development and maintenance of the company pharmacovigilance network dedicated to the highest quality standards in pharmacovigilance to prevent risks. You will support the EEA QPPV oversight, awareness and issues resolutions for the global PV network. You will organize a quarterly affiliate safety meetings (TC) Support local PV initiated projects with Local PV contacts Coordinate reconciliation activities with all data sources providing safety information to Global Drug Safety according to Omega Pharma SOPs/Work Instructions (WI) Coordinate PhV questionnaire with affiliates in relation to medicinal products and local PhV activities ensuring appropriate questions developed for the relevant PhV purpose Function as a single contact point within Global Drug Safety in relation to reconciliation activities, agreements and PhV questionnaires.
Life science degree (pharmacy, medicine, …) or equivalent through experience. You have at least 3-5 years of significant and successful experience in international Pharmacovigilance with 3 years 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.
Key words / key word - pharmacovigilance , PV , Drug Safety , International , Safety Data, PV , Belgium , Global Safety Data Exchange Agreements