Company DescriptionPrimeVigilance (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 DescriptionThe Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.Main responsibilitiesPrimary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirementsPrompt and effective communication with local regulatory authoritiesProvision of local regulatory intelligence screening and expert adviceCollection and reporting of locally suspected ADRs or ICSRs (FUs, translations)Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issuesPreparation and collection of documentation for submissions to the regulatory authoritiesReview and linguistic input on local Product Information and Mock-ups Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulationsPerform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety informationMaintain accurate records and documentation at local levelProvide support to the RA & PV Global operations teamEnsure compliance with MAH's and PrimeVigilance's proceduresSupport audits and InspectionsHandle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local marketQualificationsBachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experienceMinimum 3 years within pharmaceutical or CRO industry or regulatory authorityMinimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related positionPharmacovigilance training and/or working experience and other educational or professional background as required by local regulationsPrior experience in Regulatory Affairs is preferred but not mandatoryExpert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competencyProficiency in English and French, both written and verbalStrong skills in Microsoft Office applications, including Word, Excel, and PowerPointAdditional InformationWhy PrimeVigilanceWe 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
