Local Contact Person, Pharmacovigilance and Regulatory Affairs

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September 10

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ERGOMED

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Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Act as primary local contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance • Prompt and effective communication with local regulatory authorities • Provision of local regulatory intelligence screening and expert advice • Collection and reporting of locally suspected ADRs or ICSRs (follow-ups, translations) • Local management/oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues • Preparation and collection of documentation for submissions to the regulatory authorities • Review 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 regulations • Perform local non-indexed literature screening and screening of regulatory authority websites for potential ADRs and safety information • Maintain accurate records and documentation at local level • Provide support to the RA & PV Global operations team • Ensure compliance with MAH's and PrimeVigilance's procedures • Support audits and inspections • Handle local QA tasks such as suspected falsified products, quality alerts and other quality-related requirements from the local market

🎯 Requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience • Minimum 3 years within pharmaceutical or CRO industry or regulatory authority • Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related position • Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations • Prior experience in Regulatory Affairs is preferred but not mandatory • Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency • Written and verbal proficiency in at least one of these languages: Dutch, Croatian, Czech, French, German, Italian, Polish or Spanish • Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

🏖️ Benefits

• 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 • Prioritisation of employee experience, well-being and mental health • Emphasis on work–life balance • Inclusive, equal opportunities workplace