Pharmacovigilance Specialist

Established in 1997, COMAC MEDICAL is a trusted and forward-thinking CRO delivering tailored, innovative solutions to leading pharmaceutical and biotechnology partners. With a strong presence across Europe and a talented team of 250+ professionals, we are committed to excellence, agility, and scientific rigor in every phase of clinical development. We are currently seeking a Pharmacovigilance Specialist to join our Regulatory & Pharmacovigilance team. This opportunity is ideal for a proactive, detail-oriented professional who is passionate about patient safety, regulatory compliance, and contributing to the successful delivery of clinical research projects. Pharmacovigilance Specialist Key Responsibilities Manage and maintain project-specific safety databases. Process and oversee Serious Adverse Event (SAE), pregnancy, and safety reports from clinical studies. Ensure timely submission of ICSRs, SUSARs, and other regulatory safety reports. Prepare and distribute safety communications to investigators and stakeholders. Support safety documentation, including DSURs, PSURs, PBRERs, RMPs, and Safety Management Plans. Conduct literature reviews and support SAE reconciliation activities. Contribute to Pharmacovigilance System Master Files (PSMFs), SOPs, and pharmacovigilance processes. Support audits and inspections related to Drug Safety and Pharmacovigilance. Act as a Subject Matter Expert (SME) and support knowledge sharing within the team. Collaborate effectively with cross-functional teams and perform additional duties as required. Required Experience & Qualifications Graduate or postgraduate degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related field. Minimum 2 years of experience in Pharmacovigilance or Drug Safety. Good knowledge of ICH-GCP, GVP guidelines, and applicable pharmacovigilance regulations. Experience with safety databases and adverse event case processing. Excellent organizational, communication, and interpersonal skills. Ability to work independently, prioritize tasks, and meet deadlines. Professional proficiency in English. Proficiency in Microsoft Office (Word, Excel, PowerPoint). Nice to Have Experience with clinical trials and post-marketing pharmacovigilance activities. Experience preparing aggregate safety reports and risk management documentation. Experience participating in audits and regulatory inspections. Additional language skills. Profile The ideal candidate is a proactive, detail-oriented, and practical professional with a strong commitment to patient safety and quality. They demonstrate excellent analytical skills, a collaborative mindset, and the ability to work effectively in a fast-paced international environment while managing multiple priorities. Why Join us? At COMAC MEDICAL, your expertise matters - and so does your growth. Work alongside experienced, supportive, and highly motivated colleagues Join a diverse, international, and collaborative work culture Gain exposure to complex studies across multiple therapeutic areas, including early-phase programs Access development opportunities and clearly defined career advancement Competitive compensation and continuous training support Ready to make a significant impact in the world of clinical research? Join Comac Medical and be part of a team that's shaping the future of healthcare. Apply now and embark on a journey of professional growth, innovation, and success!