PrimeVigilance, part of the Ergomed Group, is a specialized pharmacovigilance service provider founded in 2008. Recognized for continuous global growth, we provide exceptional support to pharmaceutical and biotechnology partners worldwide. With a presence across Europe, North America, and Asia, PrimeVigilance offers services across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Committed to employee well-being and career development, we foster a supportive environment that promotes work-life balance, inclusion, and growth. If you want to make an impact in the medical field while working with a company that values integrity, quality, and collaboration, PrimeVigilance is the place to be!
Responsibilities of Medical Reviewer I
The Medical Reviewer I will play a crucial role within the PV Medical Group. Your main responsibilities include:
- Evaluating, analyzing, and reviewing adverse events and case reports to ensure compliance with global safety regulations.
- Performing medical assessments for reported events and providing professional feedback for pharmacovigilance databases.
- Collaborating with internal teams and external clients to maintain high-quality standards.
- Ensuring that safety data is correctly documented and submitted according to established timelines and procedures.
- Reviewing literature for relevant safety information and contributing to regulatory documents and risk-benefit assessments.
- Participating in cross-functional meetings to discuss complex cases and safety concerns.
Qualifications for Medical Reviewer I
To succeed in this role, the following qualifications are essential:
- Degree in Medicine or Life Sciences (MD, MBBS, BPharm, or related healthcare background preferred).
- Prior experience in pharmacovigilance or clinical research is an advantage.
- Familiarity with international regulatory requirements (such as EMA, FDA, and ICH guidelines).
- Excellent communication and report-writing skills in English.
- Ability to work independently while maintaining collaborative partnerships across global teams.
Skills Required
- Attention to Detail: Ensuring all medical data is accurately documented and reviewed.
- Analytical Thinking: Capability to assess and interpret clinical data.
- Time Management: Ability to meet strict deadlines and manage multiple tasks simultaneously.
- Teamwork and Adaptability: Collaborating effectively in a fast-paced, international environment.
- Technical Proficiency: Working knowledge of pharmacovigilance databases and software tools is preferred.
