Drug Safety and Pharmacovigilance Consultant Drug Safety and Pharmacovigilance Consultant Get AI-powered advice on this job and more exclusive features. Direct message the job poster from ClinChoice Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for Area Safety Head Consultant (Local PV UK, Ireland, Nordics) for 12 months Contract with possibility of extension to join one of our clients. Hybrid – 2 to 3 days a week Location - 50-100 Holmers Farm Way, High Wycombe UK The Area Safety Head is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners. This role will act as the Local Operating Company (LOC)’s and assign territories (as applicable) main point of contact for pharmacovigilance matters with the local health authority. They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Main Job Tasks and Responsibilities: Act as Local Nominated Person: Function as nationally nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law. Collaborate with the QPPV offices as required. Oversight of the PV System & Overall responsibilities : Provide line management and/or oversight of vendor resources in the countries in scope. Function as a delegate for the Regional Safety Head, when required. Managing and coaching the direct reports as applicable. Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level. Escalate compliance issues in a timely manner to Regional Safety Head to ensure appropriate mitigation is implemented. Advise the local business on the PV impact of local organized data collection programs. Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs. Identify periods of high PV workload and manage PV resource appropriately to address them. Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable. Safety Management & Reporting: Maintaining oversight of local requirements for pharmacovigilance, cosmetic and device vigilances, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements. Maintain oversight on day-to-day AE inbound and outbound reporting as applicable. Supporting in the responses to safety-related health authority queries in the territory if applicable. Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding safety. Accountable for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities. Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general. Perform translation for ICSR and PV-related documents, as required. Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC. Procedural Document: Ensure implementation of the local procedures where applicable and assess the impact of changes to the global procedure to local procedures. Audit & inspection readiness: Lead local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable. PV contract management Maintain an oversight into the local PVAs and ensure local implementation, including LSU training and adherence to PVAs. Business