Medical Review Team Manager/Operations Manager
Graduate/Post Graduate/Doctorate degree in medical sciences or equivalent degree (MBBS / MD)
Minimum 2 years of experience in medical review of ICSR or minimum 1 year of experience in aggregate analysis.
- Personal grooming and etiquette
- Inter personal effectiveness
- Achievement orientation
- Relationship building ability
- Interface with other departments
- Inclination towards being process driven
- Punctuality and discipline
- Fluency in English
- Online and offline Medical Review of safety reports in Argus Core and through line listing.
- Review and validation/amendment of product coding.
- Review/amendment of narrative for its appropriateness as per narrative writing conventions
- Review and validation/amendment of event selection, coding (as per MedDRA current version), grouping/ linking and event ordering.
- Review and validation/amendment of seriousness criteria (as per applicable WP)
- Support medical function for the assigned activities
- Review and confirmation/amendment of Expectedness / Listedness / Labeling of the event
- Determination and addition of causality (as per applicable WP)
- Providing Medical Assessment Comment (MAC), where applicable (as per applicable WP).
- Requesting for relevant follow-up information
- Action item generation
- Certain countries non serious cases have to be reviewed Responding to medical
queries raised by the case processors and QC (Quality Control) associate and provide
feedbacks to them
- Reporting to Team leader/Team manager on performance, status and any escalations
- Provide triage support for medical judgement related queries.
- Participating in product safety meetings
- Responsible to conduct Best practice sessions amongst team for quality improvement.
- Confirm to established productivity metrics
- Quality Metrics: Target for quality to be met as per the agreed Service Level
- Leaves to be managed as per the company policy
- Ensure training compliance is met at all times.
Apply through this Link