At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and creative solutions to improve patient health; andPartnership – Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference and here’s how the Deputy Manager- Global PV Operations role, will make an impact:Role Purpose:As a Medical Reviewer PV Operations:· Perform medical review and assessment of ICSRs.· To assist the Manager, PV Operations/designee in executing the PV activities pertaining to· Case processing regarding global PV requirements, as per existing regulations.· Assist the global PSRM in various PV related activities.As a NDR Vigilance Medical Reviewer:· Perform NDR medical review and assessment of ICSRs.· To assist the Lead, NDR Vigilance Medical Reviewer, PV Operations/designee in executingthe NDR activities pertaining to case processing regarding global NDR requirements, as perexisting regulations.· Assist the global PSRM in various NDR Vigilance related activities.Responsibilities:Medical Reviewer PV Operations· Attend to the daily workload of ICSRs that gets assigned by the manager, PVOperations/designee and any other tasks relevant to PV activities.· Perform the medical review (MR) of ICSRs into the Argus global safety database in stipulatedtimelines in accordance with the corporate quality standards and in accordance with theinternational regulatory requirements.· Follow-up for serious cases where information is required for further medical assessmentand targeted Follow-ups. Second medica triage of non-serious cases. Potential signalidentification and notification during ICSR review. French method of imputability for Francecases.· Generation and review of SOPs and work practice document (WPD) as and when required.· Ensuring compliance with regulatory requirements and company SOPs. To be aware of andkeep abreast of the new regulations affecting PV activities in India and other regions asapplicable.· Conduct training approved by Manager,



PV Operations/designee and provide guidance toProcess associates on medical aspects of case processing and Mylan Vendors. Training andmentoring of new joinee medical reviewers.Communicate new or change in regulations to Manager, PV Operations/designee and tothe relevant members of the department to initiate any change in the processes.· Build and maintain good relationships across functional units and company affiliates.· Medical review support for retrospective quality control process of individual case safetyreports.NDR Vigilance Medical Reviewer· Attend to the daily workload of Individual Case Safety Reports (ICSRs) that gets assignedby the manager, Pharmacovigilance (PV) Operations/designee and any other tasksrelevant to PV activities.· Act as Back-up of Non-Drug (NDR) Vigilance Medical Reviewer according to his/her tasksand responsibilities· Managing Individual ICSRs of the company coming from the Affiliate SafetyRepresentative (ASR) - Medical Devices, Food Supplements, Cosmetics, Biocides.· Perform the Medical Review (MR) and assessment of ICSRs into the NDR Argus globalsafety database in stipulated timelines in accordance with the corporate qualitystandards and in accordance with the international regulatory requirements.· Assess seriousness, causality, listedness and company comment ICSRs & Record ICSRsin the Global Safety Database (Argus): Medical Review· Check ICSRs data for consistency and accuracy and request to NDR safety specialistfollow-up for ASR on missing information required for further medical evaluation· Under manager overview, drafting the documents for Health Authorities in case ofSerious Incidents (medical devices, in vitro diagnostic)· For cosmetic products: Under Manager overview, drafting the documents for HealthAuthorities in case of Serious Undesirable Effect for cosmetics· Review scientific/clinical protocols, synopsis, agreement,



and other documentation forthe Safety Details· Generation and review of Standard Operating Procedures (SOPs) and work practicedocument (WPD) as and when required.· Ensuring compliance with the regulatory requirements and company SOPs. To be awareof and keep abreast of the new regulations affecting PV activities in India and otherregions as applicable.· Conduct training approved by Manager, PV Operations/designee and provide guidanceto process associates on medical aspects of case processing. Training and mentoring ofnew joiner medical reviewers.· Communicate new or change in regulations to Manager, PV Operations/designee and tothe relevant members of the department in-order to initiate any change in theprocesses.· Build and maintain good relationships across functional units and company affiliates.· Medical review support for retrospective quality control process of individual casesafety reports.· For cosmetic products: reviewing artworks and technical data sheet and similardocuments for compliance with current product information file and/or tests· Responsible for review of safety details in the Clinical Study Documentation.Position Accountability / Scope:· Decision making authority and controls: The job holder will be required to prioritize work,based on expected or agreed timelines. Keeping the best interests of the NDR Vigilancedepartment in mind, he/she may need to take decisions on the action plan to achieve theexpected outcome. Should there be any process related deviations from definedregulations or company’s best practices, advice should be sought from the Lead, NDRVigilance Medical Reviewer, NDR Vigilance operations.· Work relationships: Whenever necessary interact with the relevant departments likeregulatory, business development, clinical etc; to meet timelines and achieve the requiredoutcome.Qualification and Experience:· Bachelor of Medicine and Bachelor of Surgery (MBBS).· Knowledge and experience of pharmacovigilance.· Knowledge of ICSRs processing.· Knowledge of Global PV regulatory processing / Global NDR Vigilance regulatoryrequirements of ICSRs of ICSRs processing.· Good time management skills with an ability to prioritize and plan the work for a productiveand effective outcome.· Good presentation, innovative and communication skills.· Good decision-making abilities

📌 Deputy Manager- Medical Reviewer PV Operations (Vasanth Nagar)
🏢 Viatris
📍 Vasanth Nagar