Deputy Manager- Medical Reviewer PV Operations

Viatris · India

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): Medical Review

· Check ICSRs data for consistency and accuracy and request to NDR safety specialist

follow-up for ASR on missing information required for further medical evaluation

· Under manager overview, drafting the documents for Health Authorities in case of

Serious Incidents (medical devices, in vitro diagnostic)

· For cosmetic products: Under Manager overview, drafting the documents for Health

Authorities in case of Serious Undesirable Effect for cosmetics

· Review scientific/clinical protocols, synopsis, agreement, and other documentation for

the Safety Details

· Generation and review of Standard Operating Procedures (SOPs) and work practice

document (WPD) as and when required.

· Ensuring compliance with the 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. Training and mentoring of

new joiner medical reviewers.

· Communicate new or change in regulations to Manager, PV Operations/designee and to

the relevant members of the department in-order 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.

· For cosmetic products: reviewing artworks and technical data sheet and similar

documents 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 Vigilance

department in mind, he/she may need to take decisions on the action plan to achieve the

expected outcome. Should there be any process related deviations from defined

regulations or company’s best practices, advice should be sought from the Lead, NDR

Vigilance Medical Reviewer, NDR Vigilance operations.

· Work relationships: Whenever necessary interact with the relevant departments like

regulatory, business development, clinical etc; to meet timelines and achieve the required

outcome.

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 regulatory

requirements of ICSRs of ICSRs processing.

· Good time management skills with an ability to prioritize and plan the work for a productive

and effective outcome.

· Good presentation, innovative and communication skills.

· Good decision-making abilities