Senior Team Member – PV Operations

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 dynamic 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)