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Medical Reviewer - Remote

Posted 3 days ago
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Full Time
India

Overview

The Medical Reviewer at PrimeVigilance will be responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, ensuring compliance with pharmacovigilance standards and contributing to patient safety.

In Short

  • Review and approve ICSR and SAE reports.
  • Act as a Qualified Person for Pharmacovigilance.
  • Provide input for Periodic Safety Update Reports.
  • Review literature for safety-related findings.
  • Cooperate in Risk Management Plans.
  • Support regulatory authority requests.
  • Participate in signal detection activities.
  • Evaluate and categorize safety signals.
  • Prepare and review benefit-risk reports.
  • Work collaboratively across teams and cultures.

Requirements

  • Medically qualified physician.
  • Experience in pharmacovigilance.
  • Ability to review aggregate report types.
  • Expertise in signal detection.
  • Strong interpersonal skills.
  • Excellent organizational skills.
  • Effective cross-cultural communication.
  • Advanced English proficiency.
  • Proficient in MS Office.

Benefits

  • Training and career development opportunities.
  • Emphasis on personal and professional growth.
  • Supportive working environment.
  • Opportunity to work globally with English as the company language.
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Ergomed

Ergomed is a specialized mid-size pharmacovigilance service provider, established in 2008, and is part of the Ergomed group. With a commitment to global organic growth, Ergomed has built a strong presence across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company prides itself on maintaining long-lasting relationships with pharmaceutical and biotechnology partners, covering all therapy areas, including medical devices. Ergomed values its employees by investing in their training and development, promoting well-being and mental health, and fostering a healthy work-life balance to ensure high-quality client service.

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