Job Title: Medical Reviewer I
Location: Remote
Employment Type: Full-time
Department: PV Medical Group
Company Overview:
PrimeVigilance, a part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider founded in 2008. With a presence across Europe, North America, and Asia, we deliver expert support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology companies of all sizes.
We cover a wide range of therapeutic areas, including medical devices, and are proud of our consistent global growth and long-term partnerships. PrimeVigilance fosters a healthy work-life balance, offering excellent training, development opportunities, and a supportive environment.
Job Description:
The Medical Reviewer I plays a critical role in ensuring patient safety by performing medical review of Individual Case Safety Reports (ICSRs), literature review, and contributing to signal detection reports and aggregate safety reporting.
Key Responsibilities:
Case Review and Approval:
Review and approve post-marketing ICSRs and Serious Adverse Event (SAE) reports from clinical trials.
Assess causality, seriousness, listedness/expectedness, and write Company comments and follow-up questions.
Conduct Analysis of Similar Events (ASE) and ensure accurate documentation, including trackers.
Literature Review:
Review literature search strategies to identify potential ICSRs, SAEs, or other safety-related findings.
Evaluate articles for their relevance to medicinal products under review.
Aggregate Reports and Signal Detection:
Review and provide input for Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
Participate in signal detection activities, including preparing reports and proposing actions for identified signals.
Collaboration and Documentation:
Work cross-culturally and cross-functionally with teams to ensure compliance and efficiency.
Maintain clear and comprehensive records for all activities.
Qualifications:
Medical Background:
Physician with demonstrated experience in pharmacovigilance.
Desirable Experience:
Familiarity with aggregate safety reports and signal detection processes.
Skills:
Strong interpersonal, organizational, and prioritization skills.
Ability to work effectively in a team-oriented, multicultural environment.
Excellent written and verbal communication skills in English.
Proficiency in presentations and documentation.
Why Join PrimeVigilance?
Employee-Centric Culture:
We embrace diversity, equity, and inclusion, fostering a workplace where all employees can grow and thrive.
Opportunities for Growth:
Comprehensive training and career development programs.
Strong emphasis on personal and professional growth.
Global Collaboration:
Work with a team of professionals worldwide, with English as the company language.
Supportive Environment:
Friendly and inclusive workplace culture that values teamwork and innovation.
Core Values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
If you're ready to make a positive impact on patient safety and resonate with our values, we look forward to receiving your application. Join PrimeVigilance and become part of a global team making a difference!
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