Senior Pharmacovigilance Consultant, Alliance Management

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Senior Pharmacovigilance Consultant, Alliance Management, implements and maintains Alliance Management services for ProPharma clients, such as covering the role of a Local Contact Person Responsible for Pharmacovigilance (LPPV), coordinating LPPV networks, maintaining the Pharmacovigilance System Master FIle (PSMF), managing Pharmacovigilance Services Agreements (PVSAs)/Safety Data Exchange Agreements (SDEAs). Essential functions: Coordinates and oversees LPPV networks, ensuring compliance with regulatory and client requirements, maintaining vendor oversight and performance, driving process improvements, managing stakeholder engagement, supporting PV governance activities, and facilitating effective communication and collaboration across teams to promote patient safety and operational excellence; Sets up and performs routine updates of PSMFs and associated annexes, ensuring documentation remains accurate, current, and aligned with regulatory and client requirements; Supports and maintains the Alliance Management processes within ProPharma, identifying opportunities to develop and enhance the process where appropriate; Serves as an LPPV in accordance to the applicable Role Description; Drafts SDEAs on behalf of clients and with client’s contractual partners, including their review and negotiation, as well as PVSAs and Statements of Work (SoWs) between ProPharma and its local pharmacovigilance service providers; Drafts and/or reviews Pharmacovigilance Management Plans (or equivalent documents) where Alliance Management services are being contracted; Supports client audits and inspections. Necessary Skills and Abilities: Must have been educated to a BSc or higher within a life-sciences or industry related discipline At least 4 years or more working in Clinical/Post Marketing Pharmacovigilance Must have at least 2 years experience working in alliance management Thorough understanding of the PV/Regulatory landscape within the UK/EU Excellent attention to detail and focus on quality; Proactive and positive approach; Very good written and oral communication skills; Sound planning, prioritizing and organizational skills; Very good decision making and problem-solving skills; Able to liaise and negotiate efficiently with clients to ensure the client needs are met; Able to work within a team in an open and professional manner; Ability to manage multiple projects. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***