MBBS Job – Senior PV Operations Role at Cipla | Apply
An exciting MBBS Job opportunity is open for the position of Senior Team Member – PV Operations at Cipla Ltd. in Maharashtra. This role focuses on global pharmacovigilance operations, medical review, and drug safety compliance, making it ideal for professionals seeking growth in Cipla careers and Cipla jobs within the pharmacovigilance domain.
Job Details:
- Job Title: Senior Team Member – PV Operations
- Country: India
- State: Maharashtra
- Location: Vikhroli
- Req Id: 102337
About the Company
Cipla Ltd. is a leading pharmaceutical organization known for its strong commitment to patient safety, regulatory compliance, and global healthcare standards. With a focus on innovation and pharmacovigilance excellence, Cipla careers offer dynamic growth opportunities for medical professionals across drug safety and regulatory domains.
Job Description
Execute and sustain global drug safety practices for the medical function to ensure Pharmacovigilance obligations are met. This MBBS Job under Cipla jobs involves case processing, aggregate report review, signal detection, regulatory intelligence activities, and ensuring global compliance with pharmacovigilance regulations.
Qualifications
- 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).
Key Responsibilities:
1. Case Processing & Regulatory Compliance
- 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.
2. Aggregate Reports & Safety Surveillance
- 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.
3. Signal Detection & 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.
4. Regulatory Intelligence & HHE
- 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).
- Review of Health Hazard Evaluations from a medical perspective based on product quality complaints in a timely manner.
5. Training & Stakeholder Coordination
- Provide PV training to employees, licensing partners of Cipla Ltd., service providers if required.
- Provide training on MedDRA updates.
- Co-ordinate with internal/external stakeholders and service providers.
- Perform QPPV activities for assigned regions, if any.
