- 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 reviewAnalyses 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, includingFDA,ICH GCP,MHRA,PMDA, andEU 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
