Medical Reviewer

THE POSITION:

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. This position based on experience may be involved in Literature review, Aggregate periodic reports, Signal management, Medical safety monitoring or Pharmacovigilance activities for assigned projects. Medical reviewer will act as Subject Matter Experts (SME) and will help train the case processing team and newly onboarded team members. Medical reviewer will be involved in audits/inspection.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

 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.

 Perform literature review analysis

 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

 Additional responsibility could include

o Provide inputs to medical writers and do medical review of various global regulatory aggregate safety reports including PADER, PBRER, ACO, PSUR.

o Should be aware of end-to-end signal management process.

o Provide inputs to medical write and help prepare safety evaluation report.

o Take part in signal management committee meetings

 Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

 Education- MBBS/MD or BDS/MDS or comparable education

 Experience and/or Training- At least 1–2-year experience as Medical Reviewer for ICSRs in pharmaceutical, biotech, medical device and/or CROs. CRO experience highly desirable.

 Regulatory guidelines expertise: knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.)

 Excellent interpersonal and organizational skills.

 Excellent written and verbal communication skills.  Must be proficient with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).