Thrive in a dynamic role as a Medical Review Specialist

1 week ago

Delhi Mumbai Kolkata, India beBeeMedicalReviewer Full time US$ 90,000 - US$ 1,20,000

Job Title: Medical Review Specialist

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  • Perform thorough medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including analysis of narrative content, coding, expectedness, seriousness, causality, and company summary to meet service level agreements and regulatory timelines.
  • Edit and medically review Analyses of Similar Events (AOSE) for expedited cases as required by regulatory guidelines.
  • Serve as an internal expert and consultant for the pharmacovigilance case processing teams.
  • Safety Data Analysis
  • Maintain a deep understanding of the scientific basis for therapies, drug-induced diseases, medical devices, vaccines, and the drug development process.
  • Continuously acquire and maintain knowledge of product safety profiles across therapeutic areas and the corresponding regulatory requirements.
  • Conduct process improvement activities, including the implementation of quality control processes and providing feedback to case processors on discrepancies or errors.
  • Training and Mentoring
  • Support training and mentoring for case processing/medical review personnel as required.
  • Actively contribute to the organization's initiatives to meet business and regulatory objectives.
  • Regulatory Compliance
  • Ensure compliance with international regulatory guidelines, including FDA , ICH GCP , MHRA , PMDA , and EU Clinical Trial Directive .
  • Stay informed on medical safety and regulatory industry developments to ensure adherence to changing standards.

Key Responsibilities:

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  • Travel: Less than 5%
  • Hours: 45 hours per week
  • This position may include additional duties as assigned.

Requirements:

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  • Education and Experience:
  • MBBS, MD, BDS, or MDS degree.
  • 1-2 years of experience as a Medical Reviewer for ICSRs in the pharmaceutical, biotech, or medical device industries. CRO experience is highly desirable.
  • Skills and Knowledge:
  • Strong understanding of pharmacovigilance regulations, including expertise in international guidelines (FDA, ICH GCP, MHRA, PMDA, GVP, EU Clinical Trial Directive).
  • Excellent interpersonal, organizational, and communication skills (both written and verbal).
  • Proficiency in MS Office applications (Outlook, Excel, Word, PowerPoint).

Cultural Values:

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  • Patient-Centric: We act with the patient's best interest in mind.
  • Client Satisfaction: We own every client experience and its impact on results.
  • Take Initiative: We are empowered and empower others to act now.
  • Talent Development: We own our development and invest in the development of others.
  • Teamwork: We passionately connect with anyone, anywhere, anytime to achieve results.
  • Effective Communication: We create transparent, thoughtful, and timely dialogue.
  • Diversity and Inclusion: We create an environment of awareness and respect.
  • Innovation: We are bold and creative in everything we do
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