Reviewer

Job Title: Medical Reviewer (Device)

Job ID: 379725

Domain: Life Sciences

Minimum Qualification: MBBS or Equivalent

Location: Mumbai / Ahmedabad

Schedule: General Shift

Set up: Work from Office

Band: BPOBPO 3/4

Salary range:9 - 11 LPA

Skills required:

• Computer Literate (e.g., knowledge of MS Office)

• 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

Medical Reviewer in pharmacovigilance is a non-clinical job where the doctor/physician reviews the individual patient’s adverse events details, in an online safety database on the computer, to assess the possibility of the drug leading to those unpleasant occurrences.

Terms explained further:

• Non-clinical - not relating to, involving, or concerned with the direct observation or management of patients)

• Doctor/physician - modern medicine graduate i.e., minimum MBBS Equivalent or above

• Adverse events - potential unpleasant outcomes after the administration of a drug [may or may not be related to the drug]

• It is a full time working from office job for physicians with an aptitude for taking up this non-clinical career for long term, and requiring the below essential skills to be successful in the role: computer/laptop use skills, an aptitude for self-directed learning, good medical & clinical knowledge, good problem solving and decision-making skills, self-motivated, ability to prioritize and plan effectively and with excellent interpersonal and communication skills; and a team player with ability to function in a multi – disciplinary environment with colleagues from different qualifications and backgrounds.

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 & 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 and TCS, policies, procedures, and processes.