Medical Reviewer

2 months ago

Pune, India EVERSANA Full time
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to the market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us
Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.
Job Description
JOB DESCRIPTION:
The most important aspect of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance, and all medical aspects of PV.
Key Responsibilities For This Role
  • Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary within the stipulated time to comply with service level agreements and regulatory timelines.
  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
  • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
  • Deep understanding of the scientific basis for therapies and drug-induced diseases. Knowledge of medical device, vaccines and drug development process;
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
  • Involve in process improvement activities such as implementation of quality control process.
  • Provide timely feedback to case processors on the errors/discrepancies noted.
  • Assist in training/mentoring of other case processing/medical review personnel as necessitated.
  • Participate in organizational activities to meet objectives suitable for the role/area of expertise.
  • Maintain awareness of medical-safety-regulatory industry developments
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