- Perform 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.
- Travel : Less than 5%
- Hours : 45 hours per week
- This position may include additional duties as assigned.
- Required Qualifications :
- 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).
- Patient Minded : We act with the patient s best interest in mind.
- Client Delight : We own every client experience and its impact on results.
- Take Action : We are empowered and empower others to act now.
- Grow Talent : We own our development and invest in the development of others.
- Win Together : We passionately connect with anyone, anywhere, anytime to achieve results.
- Communication Matters : We create transparent, thoughtful, and timely dialogue.
- Embrace Diversity : We create an environment of awareness and respect.
- Always Innovate : We are bold and creative in everything we do
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Medical Reviewer - Bengaluru / Bangalore - Thepharmadaily
Description
Job Expectations
Education and Experience
Cultural Beliefs at EVERSANA
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Medical Reviewer
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