Division
Department
Sub Department 1
Job Purpose
Execute and sustain global drug safety practices for medical function to ensure Pharmacovigilance obligations are met.
Key Accountabilities (1/6)
Perform case processing activities related to PV safety to ensure regulatory compliance globally
Assign a degree of urgency (triage) for each individual case safety report by checking the listed-ness and seriousness of the case, and providing expert comments based on medical review, as required by the regulatory guidelines
Review appropriate medical cohesiveness of the data captured by drug safety specialists and associates based on medical judgement
Perform PPQC of cases on monthly basis and ensure completion within SOP specified timelines.
Respond to adhoc queries from the cases processing team • Provide guidance on MedDRA coding
Act as a point of contact for resolving queries being raised by internal/external stakeholders.
Key Accountabilities (2/6)
Analyse Aggregate reports and safety surveillance data to ensure safety profile of the drug and patient safety
Conduct medical review of ASRs such as RMP/BR, PADER, PSUR, PBRER and other PV documents to ensure appropriate medical cohesiveness of data across reports
Provide inputs and expert medical feedback on the reports and send back to the author for updating
Review the regulatory intelligence data for safety signals to ensure compliance with regulatory requirements
Support the team by providing documents and auditor responses as required to facilitate smooth and successful inspection
Provide documented reports based on the requirement of the auditors
Key Accountabilities (3/6)
Support with Signal detection activities and AdHOC Health Authority requests
Provide inputs on signal detection,



validation and prioritization for ongoing safety surveillance and signal detection/analysis activities including aggregate data review/trend analysis based on historical data
Review draft signal report for medical cohesiveness
Present and/or participate in Drug Safety Review Committee (DSRC) meetings.
Analyse and review health authority response reports prepared by medical writing team
Submit reports on ad-hoc internal/external trigger to the regulatory authority if required
Key Accountabilities (4/6)
Support with Regulatory Intelligence (RegIntel) Activities
Review the regulatory intelligence data for safety signals to ensure compliance with regulatory requirements
Notify PV operations team (as applicable) of the regulatory updates (if any).
Health Hazard Evaluation (HHE)
Review of Health Hazard Evaluations from a medical perspective based on product quality complaints in a timely manner
Key Accountabilities (5/6)
Training
Provide PV training to employees, licensing partners of Cipla Ltd., service providers if required.
Provide training on MedDRA updates
Others
Co-ordinate with internal/external stakeholders and service providers
Perform QPPV activities for assigned regions, if any
Key Accountabilities (6/6)
Major Challenges
Keeping updated with the ever changing agile regulatory requirements – To overcome, constantly retraining and up-skilling to be in line with the regulatory expectations
Non availability of a centralized and up-to-date product list and pack inserts to assess the safety profile of drugs
Multiple internal and external stakeholder interactions
Key Interactions (1/2)
Internal




Medical writing team for aggregate reports such as PBRERs, PSURs, RMPs, PADERs, Safety Summary Reports (SSR), PV Plans which require risk assessment, search criteria, signal data evaluation, etc.
Mailbox team for complaints evaluation, rapid alert notifications, and other queries requiring medical judgement,
ICSR (Case processing and reporting teams) for medical review of cases including medical opinion of cases, opinion on regulatory reporting challenges, etc.
Labelling team for matters related to label updates and other issues pertaining to safety profile of drugs (regular)
Key Interactions (2/2)
External
Auditors during inspections/ audits (if required)
Service providers / Contractual partners for supporting in resolving challenges if any.
Dimensions (1/2)
Review of complaints / cases received from mailbox team: approx. 25 complaints/ cases received / month
Medical review: 10% post-procedural quality checks of cases received / month (~300)
Review and approval of Aggregate Case Reports and RMPs: 15 reports / month
Review and approval of signal data on a 6 monthly basis
Dimensions (2/2)
Key Decisions (1/2)
Decisions
Causality assessment
Identification and reporting of safety issues
Signal evaluation
Key Decisions (2/2)
Recommendations
Recommendations to manager on improvements in in set processes for the medical function
Case triage based on seriousness, listed-ness of events, to manager
Ensure adequate documentation of decisions and actions taken throughout the assessment of observations from disproportionality analysis of a potential signal.
Education Qualification
Minimum requirement - MBBS
Relevant Work Experience
2-3 years of experience as a Medical Reviewer across Drug Safety/PV domain in case processing (add on would be an experience as medical reviewer of aggregate reports and signal detection)

📌 Senior Team Member Pv Operations (India)
🏢 Cipla
📍 India