Specialist, Regulatory and Pharmacovigilance Network (Delivery)- remote in UK in Manchester

PrimeVigilance (part of Ergomed Group) is a specialised mid‑size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first‑class support to our small to large pharmaceutical and biotechnology partners, maintaining long‑lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical devices. We invest in our staff by providing an excellent training and development platform, valuing employee experience, well‑being, mental health and a healthy work‑life balance. We invite you to join us on an exciting journey to make a positive impact in patients’ lives.

The Specialist, Regulatory and PV Network (Delivery) is responsible for providing strategy based on regulatory requirements and completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in planning, organizing, and preparing regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.

Job Responsibilities:

• Assume leadership and functional representation for projects of low complexity under the direction of a senior team member, ensuring effective coordination and management of deliverables to meet agreed targets and comply with procedures, trackers and templates.
• Provide intelligence on requirements and contribute to development of strategy and set‑up activities (Project Management Plan, joint operating procedures, POAs and core documents).
• Support identification of issues and corrective actions.
• Collect, review, track and maintain LCPs’ CVs, job descriptions, training records, contact details and monthly reports; ensure correct training assignment and compliance.
• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
• Provide clients expertise and guidance at national level.
• Maintain awareness of allocated tasks and hours and promptly identify and escape any out‑of‑scope issues.
• Prepare client invoices and review/approve vendors’ project invoices.
• Support proposal development and input to budgets; represent department at BD meetings as required.
• Foster professional working relationships with internal and external contacts locally and internationally to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements, maintain the regulatory intelligence database and disseminate pertinent changes.
• Participate in preparation for audits/inspections and provide department representation for assigned projects.
• Track LCPs’ key performance indicators and prepare monthly summary reports.
• Provide feedback on performance of vendors to aid assessment.
• Communicate suggestions for changes to departmental/company processes and procedures.
• May act as Local Contact Person for Pharmacovigilance or deputy.

Qualifications:

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
• Previous experience within the pharmaceutical/CRO industry.
• PV training and/or working experience and other educational or professional background as required locally.
• Fluent in English, both written and verbal.
• Proficiency in the official language of the country in which they are based.
• Strong planning and organizational skills.
• Excellent interpersonal skills in a fast‑paced, deadline‑oriented, changing environment.
• Good attention to detail.

Why PrimeVigilance:

• We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human‑centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
• We believe our people are our greatest strength in improving the lives of those around us.

We Offer:

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues worldwide, with English as the company language.

Core Values:

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.