Senior Associate - Medical review Physicain

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 2- 4 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)