Sr. Scientist, Medical Review Physician

Primary Responsibilities:

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, 
  expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, 
  Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, 
  Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign 
  appropriate MedDRA code, assess labelling and review narrative.
• 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 medical guidance and expert opinion on the cases to the data entry associates and 
  quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional 
  team and manage as appropriate.
• Maintain PV expertise, and understanding of international safety regulations and guidelines. 
• Responsible for completing the MR activities in the safety database within the stipulated time to 
  comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted. 
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per 
  project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Candidate Profile:

• Should be a MBBS/MD with 4 - 5 years of experience as Medical Reviewer for ICSRs. 
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and 
  other regulatory requirements.
• Training and mentoring skill (GVP concepts & medical aspects such as disease condition, 
  product portfolio etc)
• Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power 
  Point etc.).