The IPV Affairs Specialist will support the Global IPV Affairs Team in all IPV operations and compliance tasks related to the vigilance of the product portfolio under the umbrella of International Pharmacovigilance (IPV). The IPV Affairs Specialist will work in close partnership with Regional Heads, Local Safety Teams and Case Management Team to ensure adequate centralization of activities enabling process optimization and increasing efficiencies. The IPV Affairs Specialist will ensure a consistent operations approach across the regions in alignment with the Global Medical Safety (GMS) and Global Medical Organization (GMO) processes for areas of responsibility. The IPV Affairs Specialist in partnership with IPV Affairs Project Lead will lead or participate in global or regional multi-disciplinary projects and shape strategies for the projects assigned. The IPV Affairs specialist may be involved in IPV process including:
General
Serve as a Member of the Global IPV Affairs TeamBe an ambassador of the Office of the Chief Medical Officer (OCMO) culture and visionFor areas under responsibility act as Subject Matter Expert for the IPV organization, drive and/or support on finding most suitable and efficient solutions during discussions with different cross functional teams and collaborate on reviewing and streamlining applicable procedural documents.Support IPV organization on applicable operational tasks and ensure overall inspection readiness across IPV.Work in close partnership with IPV Affairs members across regions to ensure a global consistent approach for IPVIPV Project Management
Lead and/or participate as specialized function in regional or global projects for areas of expertise to streamline and optimize PV operations.Compliance oversight & Metrics for IPV
Contribute to the development of an integrated and standardized IPV quality systemDevelop a globally consistent approach for assessing, recording and reporting of countries compliance status in close cooperation with CSA international. Escalate alert signals of non-compliance.Support preparing the compliance oversight reports and meetings needed for the different stakeholders for final review by the IPV Leadership teamFocus on risk identification and support mitigation as needed.Initiate, lead, and support continuous improvement initiatives based on quality and compliance of Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs).Qualifications:
• Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance
• Minimum of 3 years’ experience in a position within Pharmacovigilance
• Proven management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment.
• Task-oriented with proven experience in the delivery of high-quality work and able to operate autonomously without direct supervision and as part of a multi-disciplinary team In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this role.
• Demonstrable insight to the development of regulatory requirements with knowledge of Global aspects of drug/devices safety, including international reporting requirements and relevant country-specific variations within the region.
• Proven Project Management experience including stakeholder management and change management
• Knowledge and experience in data management/visualization platforms a big plus (Tableau etc)
• Experience in
• Excellent computer-based application skills
• Fluent communication skills in English, any additional language is a plus
Desirable profiles and experience include:
• Experienced CAPA coaches
• Pharmacovigilance Regulations Handling experience
• Pharmacovigilance Compliance Metrics Management and Handling
• Technical knowledge and experience on data management and visualization platform (Tableau etc)
Educational Attainment:
Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance. Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Pharmacist, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
Working set up: Hybrid set up