Local Contact Person – Pharmacovigilance and Regulatory Affairs

Job not on LinkedIn

🔥 1 hour ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 18%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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.

📋 Description

• Act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) • Serve as the primary local RA and PV representative for compliance with national pharmacovigilance and regulatory requirements in Australia • Execute local pharmacovigilance and regulatory affairs activities • Support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle • Communicate promptly and effectively with the MAH and local regulatory authorities • Act as primary contact with local regulatory authorities for Regulatory Affairs and Pharmacovigilance • Provide local regulatory intelligence screening and expert advice • Collect and report locally suspected ADRs or ICSRs, including follow-ups and translations • Manage or oversee risk minimization measures related to urgent safety restrictions and emerging safety issues • Support development and implementation of the local pharmacovigilance system • Perform local non-indexed literature screening and regulatory authority website screening for potential ADRs and safety information • Maintain accurate local records and documentation • Support the RA and PV Global Operations team • Prepare and collect documentation for regulatory authority submissions • Review and provide linguistic input on local Product Information and mock-ups • Ensure compliance with MAH and PrimeVigilance procedures • Support audits and inspections • Handle local quality assurance tasks, including suspected falsified products and quality alerts from health authorities

🎯 Requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience • At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment • Good understanding of ICH GVP and local pharmacovigilance requirements • 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 • Additional language knowledge is advantageous • Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

🏖️ Benefits

• Flexible remote work • Collaborative and supportive team environment • Growth and professional development opportunities • Global work environment across Europe, North America, South America, Asia, and Australia