Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)

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

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in the United States. This 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 responsibilities Prompt and effective communication with MAH and local regulatory authorities as required Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements Provision of local regulatory intelligence screening and expert advice for the responsible region(s) Collection 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 issues Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information Maintain accurate records and documentation at local level Provide support to the RA & PV Global operations team Preparation and collection of documentation for submissions to the regulatory authorities Review and linguistic input on local Product Information and Mock-ups Ensure compliance with MAH's and PrimeVigilance's procedures Support audits and Inspections Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market

Qualifications

Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience 2-4 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure) Experience in case handling, literature screening, or local PV activities is preferred Prior experience in Regulatory Affairs is preferred but not mandatory Proficiency in English and additional language knowledge (i.e. French) is advantageous Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint 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 Department: Regulatory and PV Network Apply To This Job