Medical Reviewer

Location: Bengaluru

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

Education and Experience

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).
Cultural Beliefs at EVERSANA
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