Job Description

Hi,

We are hiring for Leading ITES Company for Medical Reviewer Profile.

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

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