Department Details
Role Summary
Global PV Activities:
• Global Operational management of end-to-end Pharmacovigilance activities like ICSR case processing, signal detection, Aggregate reports and RMP
• Authoring and maintenance of PV SOPs
• Training of new joiners in PV department
• Maintenance of aggregate report calendar.
• Post Approval REMS management in terms of Pharmacovigilance
• Access management of Agency submission portals.
• Support for regulatory inspections and audits Management of External Service Provider
• Provide support for Invoice for ESP's performing activities necessary for MICC, ICSR, PSMF-Country Specific activities for EU & UK and UAE.• Prepare/Review MSA/SoW/PMP for all outsourced activities.
• Provide monthly updates on MICC calls, ICSR and PSMF activities to management or as required.
• Monitor compliance of agreed SLAs and KPIs in terms of TAT and Quality with service providers and have oversight of RCAs and CAPAs
MICC Workflow:
• Review call logs for Quality & Resolve Queries raised from Calls.
• Coordinate between PQC/MI & Business Partner and IT & Telephone Service Provider.
• Review of Reconciliation of calls from MICC Workflow.
• Provide secondary review on cases for ICSR Quality.
• Review Literature search for Raw hits and Cases.
• BPL Mailbox Management for ICSR support.
• Coordinate between ArisG Database and Case Processing teams.
• Provide and verify Regulatory Submission Compliance for ICSR.
• Reconciliation of all ICSR's.
PV Database Activity:
• Maintenance of BPL Product Dictionary and Regulatory submission activity.
• PV Database Administration & Query Resolution.
• Review of SDEA's between Partners and BPL.
• CFT Activity: Collaboration with RA, QA, Legal, Finance, Packaging, Commercial, PQC and BBL
• To support in identification, review and investigation of possible DI issues on the shop floor and respective areas.
• To track the DI related deviations within the respective functions.
• To identify areas of DI concern and opportunity for improvement within the respective areas.
• To follow-up and ensure completion of actions identified related to DI Strategy plan at respective areas
• To participate in DI Governances meetings to share and discuss the underlying issues related to DI compliance at all sites.
• To share ideas with DI Governance team for new DI initiates within the organization.
• To support the DI Governance team during DI Audits.
• To be the POC for reporting the DI issues with the respective areas or site.
• Support for driving and facilitating the DI communications, DI Learning Sessions and DI Engagement Plan across Biocon Limited and its entities.
• Spread awareness amongst the people on the Biocon Ethical Practices & Integrity Policy, WhistlerBlower Policy and Zero Tolerance Policy.
Key Responsibilities
Global PV Activities:
• Global Operational management of end-to-end Pharmacovigilance activities like ICSR case processing, signal detection, Aggregate reports and RMP
• Authoring and maintenance of PV SOPs
• Training of new joiners in PV department
• Maintenance of aggregate report calendar.
• Post Approval REMS management in terms of Pharmacovigilance
• Access management of Agency submission portals.
• Support for regulatory inspections and audits Management of External Service Provider
• Provide support for Invoice for ESP's performing activities necessary for MICC, ICSR, PSMF-Country Specific activities for EU & UK and UAE.• Prepare/Review MSA/SoW/PMP for all outsourced activities.
• Provide monthly updates on MICC calls, ICSR and PSMF activities to management or as required.
• Monitor compliance of agreed SLAs and KPIs in terms of TAT and Quality with service providers and have oversight of RCAs and CAPAs
MICC Workflow:
• Review call logs for Quality & Resolve Queries raised from Calls.
• Coordinate between PQC/MI & Business Partner and IT & Telephone Service Provider.
• Review of Reconciliation of calls from MICC Workflow.
• Provide secondary review on cases for ICSR Quality.
• Review Literature search for Raw hits and Cases.
• BPL Mailbox Management for ICSR support.
• Coordinate between ArisG Database and Case Processing teams.
• Provide and verify Regulatory Submission Compliance for ICSR.
• Reconciliation of all ICSR's.
PV Database Activity:
• Maintenance of BPL Product Dictionary and Regulatory submission activity.
• PV Database Administration & Query Resolution.
• Review of SDEA's between Partners and BPL.
• CFT Activity: Collaboration with RA, QA, Legal, Finance, Packaging, Commercial, PQC and BBL
• To support in identification, review and investigation of possible DI issues on the shop floor and respective areas.
• To track the DI related deviations within the respective functions.
• To identify areas of DI concern and opportunity for improvement within the respective areas.
• To follow-up and ensure completion of actions identified related to DI Strategy plan at respective areas
• To participate in DI Governances meetings to share and discuss the underlying issues related to DI compliance at all sites.
• To share ideas with DI Governance team for new DI initiates within the organization.
• To support the DI Governance team during DI Audits.
• To be the POC for reporting the DI issues with the respective areas or site.
• Support for driving and facilitating the DI communications, DI Learning Sessions and DI Engagement Plan across Biocon Limited and its entities.
• Spread awareness amongst the people on the Biocon Ethical Practices & Integrity Policy, WhistlerBlower Policy and Zero Tolerance Policy.
Educational Qualifications
Required Education Qualification:
Required Experience: 8 - 13 years