Deputy Manager- Medical Reviewer PV Operations

Location: Bengaluru

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 innovative solutions to improve patient health; and
Partnership  – 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 executing
the NDR activities pertaining to case processing regarding global NDR requirements, as per
existing 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, PV
Operations/designee and any other tasks relevant to PV activities.

· Perform the medical review (MR) of ICSRs into the Argus global safety database in stipulated
timelines in accordance with the corporate quality standards and in accordance with the
international regulatory requirements.

· Follow-up for serious cases where information is required for further medical assessment
and targeted Follow-ups. Second medica triage of non-serious cases. Potential signal
identification and notification during ICSR review. French method of imputability for France
cases.

· 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 and
keep abreast of the new regulations affecting PV activities in India and other regions as
applicable.

· Conduct training approved by Manager, PV Operations/designee and provide guidance to
Process associates on medical aspects of case processing and Mylan Vendors. Training and
mentoring of new joinee medical reviewers.
Communicate new or change in regulations to Manager, PV Operations/designee and to
the 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 safety
reports.

NDR Vigilance Medical Reviewer

· Attend to the daily workload of Individual Case Safety Reports (ICSRs) that gets assigned
by the manager, Pharmacovigilance (PV) Operations/designee and any other tasks
relevant to PV activities.

· Act as Back-up of Non-Drug (NDR) Vigilance Medical Reviewer according to his/her tasks
and responsibilities

· Managing Individual ICSRs of the company coming from the Affiliate Safety
Representative (ASR) - Medical Devices, Food Supplements, Cosmetics, Biocides.

· Perform the Medical Review (MR) and assessment of ICSRs into the NDR Argus global
safety database in stipulated timelines in accordance with the corporate quality
standards and in accordance with the international regulatory requirements.

· Assess seriousness, causality, listedness and company comment ICSRs & Record ICSRs
in the Global Safety Database (Argus):
Medi…