Medical Reviewer - Chennai, Hyderabad / Secunderabad, Telangana, Pune - Thepharmadaily

Description

• 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