Job Description

Hi,

We are hiring for one of Indias leading IT & consulting organizations for the position of Medical Reviewer.

Please go through the JD and Apply. We shall call back the relevant profiles.

Key Skills :

1. Minimum 1 year of experience in Pharmacovigilance / Drug Safety / Medical Review
2. Perform medical review of adverse event cases (ICSRs) from global safety databases
3. Graduate in MBBS or MD degree (mandatory)

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
• Developing and maintaining thorough knowledge of the appropriate disease biology areas C important safety concerns for marketed drugs and drugs in development
• Assuring and maintaining compliance with regulatory and local/global SOP timelines
• Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing
• Representing 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 that is 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, policies, procedures, and processes.

Skills required:

• Aptitude for self-directed learning
• Good medical knowledge and its application in drug safety
• Sound understanding of the Drug Safety and Regulatory process
• Good problem solving and decision-making skills
• Initiative-taking, able to prioritize and plan effectively
• Excellent interpersonal and communication skills
• Team player with ability to function in a multi disciplinary environment

More Info

Education