Medical Writer III, Pharmacovigilance

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🔥 0 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥📝 Medical Writer

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Logo of ERGOMED

ERGOMED

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

• Author, review, and quality check regulatory and pharmacovigilance documents, including PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans (RMPs) • Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines • Collaborate with cross-functional teams to analyse, interpret, and present safety data • Act as a trusted client point of contact, supporting project delivery and fostering working relationships • Provide guidance, mentoring, and knowledge sharing to junior medical writers • Contribute to process improvements and enhancement of medical writing quality standards

🎯 Requirements

• MD, pharmacy, or Life Science degree • Minimum 2 years' experience in Medical Writing and associated fields (case processing, signal detection, or risk management) • Experience ideally within a CRO environment • Ability to manage multiple and varied tasks and prioritize workload with attention to detail • Ability to effectively train and mentor Associate Medical Writers • Strong team player • Fluency in English • Additional language is a benefit • Master's or PhD is desirable

🏖️ Benefits

• Remote work option • Flexible work environment • Growth and professional development opportunities • Mentoring and knowledge-sharing opportunities • Collaborative team environment • Belonging-focused workplace culture

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