PV Operations Officer - Belgium
Want to know company name or location? Company managed [?]
- 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 company BCH 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 company BCH departmental deviations relevant to the SDEA
- Collaborate with management to achieve the objectives of the Department.
- Perform ad hoc duties & projects as assigned.
- 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 purpose.
- Life science degree (pharmacy, medicine, …) or equivalent through experience.
- You have at least 3 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.