Full Time 1 month ago

Job Level Experienced Professional

Experience Less Than 1 Year

Job Type Full Time

Location Mumbai

Experience:

2-5 years

Minimum Qualification:

MBBS/MD

Job Description:

Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement).
Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history.
Develop and maintain thorough knowledge of the appropriate disease biology areas and important safety concerns for marketed drugs and drugs in development.
Assure and maintain compliance with regulatory and local/global SOP timelines.
Support the Drug Safety teams with medical concepts and awareness of product-related topics to ensure quality of adverse event data processing.
Represent the safety physician team in internal and client safety forums and audits.
Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.
Responsible for generating, sending, and tracking medically relevant queries for follow-up information required for an individual case safety report.
Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse Reaction (SUSAR).
Ensure compliance with global and local procedural documents and implementation of client and company policies, procedures, and processes.