Senior Specialist, Regulatory & PV Network (Delivery)

Job description

Company Description 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 all 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 device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Role Overview A delivery focused role combining Regulatory and Pharmacovigilance (PV) project management and coordination, responsible for ensuring timely and compliant execution of regulatory and PV activities across assigned projects. The Senior Specialist will also act as Local Contact Person for Pharmacovigilance (LCPPV) for the designated country. Core Responsibilities Project Management Manage medium/high-complexity regulatory and PV projects, ensuring delivery against timelines, scope, and quality Oversee project setup, plans, and milestones, and coordinate across clients, LCP network, vendors, and internal teams Identify and mitigate delivery risks PV & Compliance Act as LCPPV, ensuring compliance with local PV requirements and inspection readiness Support audits and inspections Team & Operations Oversee LCP documentation (CVs, training, KPIs) and ensure training compliance Contribute to process improvements and standardization Support and guide junior staff Financial & Operational Oversight Track scope, timelines, and budget, including OoS activities Support invoicing and monitor project performance, escalating deviations Qualifications Bachelor's Degree in Pharmacy Strong experience within pharmaceutical or CRO industry or Regulatory body Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency PV training and/or working experience and other educational or professional background as required locally Fluent in English, both written and verbal Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance Proficiency in German, French, or Italian is a plus but not mandatory Good planning and organizational skills Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment Good attention to detail Additional Information 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. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on 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 based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. #LI remote