Role: ? The TCP Homecare is a healthcare service provider, specialising in direct to patient services which include the dispensing and distribution of pharmaceutical products, homecare nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patients home. Job Scope: The Pharmacovigilance Lead / Manager is responsible for all elements of the pharmacovigilance function within TCP Homecare. This is full time, Monday to Friday role with attractive hybrid working available. Key Responsibilities: To act as the Pharmacovigilance point of contact for internal functional departments and external clients. Maintain the pharmacovigilance documentation system, to include SOP writing and review, AE reporting forms, work instructions. Oversee the administration and documentation of adverse events and quality complaints in line with the standard operating procedures. Ensure the standards of PV reporting are being met within TCP, and where necessary liaise with department heads to ensure compliance. Maintain the pharmacovigilance reporting system and provide systematic reporting to in-house managers and external clients. Review and identify areas of improvement Manage all aspects of the pharmacovigilance team, including recruitment, staff absence, annual leave, performance appraisal, disciplinary issues. The successful candidate will be responsible for ensuring mailbox management, case processing, reconciliation, query management and other tasks associated with ensuring pharmacovigilance procedures are met. To work as the primary point of contact for PV when dealing with external pharma companies. This includes account management of PV services, scheduling of and attendance at review meetings (where required). Collate and maintain reporting figures and KPIs on a weekly/monthly basis, contribute to trend analysis when required. Review and approve Quality agreements and Safety Data Exchange Agreements for PV and product complaints. Act as the primary point of contact for PV in audits (external, internal, regulatory).Implement a process for regular self-inspection and always maintain audit readiness. Ensure quality checks are completed and reviewed on case reports as per standard procedure. Manage and review source note samples monthly, as per client sample request (external).Liaise with patient care bureau/business analyst as required. Complete CAPA and process improvement for all audit findings. Provide and manage PV training.Oversee annual training requirements for each company, working with the TCP training co-ordinator. Contribute to contingency planning and business continuity. Provide operational support within the team as required. Manage the QMS for pharmacovigilance and product complaints, to include deviation reporting, trending of errors, corrective, and preventative actions. Keep up to date with local and European PV legislation; participate in continuing professional development and education. Act as the PV contact for tender process/business presentations as required. Your profile will ideally include: Science degree (essential) 4-5 years of pharma experience, with at least 3 years in PV (essential) Experience in project management capacity Leadership and Management Experience, including supervising/managing staff Experience in project management capacity Regulatory Knowledge: In-depth knowledge of EU pharmacovigilance legislation, GVP modules, and MHRA requirements. Client-Facing Experience: Comfortable working with multiple stakeholders across pharma and biotech clients in a service-based environment. Technical Proficiency: Familiarity with pharmacovigilance documentation systems and Quality Management systems. Strong interpersonal and written communication skills; able to work cross-functionally Fluency in English (essential) What We Offer in Return: Competitive annual salary 24 days of annual leave, rising with service Pension Scheme Life Assurance Health Insurance Income Protection Education Assistance funding with paid exam and study Leave Employee Discount Card You Can Also Expect: A supportive and friendly working environment Hybrid working, with the ability to work up to 3 days per week from home Company laptop and home office package Regular training courses and opportunities to up-skill Social events Cycle to Work scheme Skills: PV Team Management SOPs