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Medical Safety Reviewer
3 months ago
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 Medical Safety Reviewer - Pharmacovigilance (Ophthalmology) role will make an impact.
The role will assist in the global pharmacovigilance activities within global PV for Viatris in accordance with Company, international standards and regulatory requirements, as assigned.
Main Accountabilities and responsibilities (but not limited to):
1- Product safety and Aggregate reports:
- Responsible for end-to-end safety of the products’ value chain, predominantly being ophthalmologic product portfolio
- Support medical review of Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER) and Addendum to Clinical Overview (ACO) related activities (including but not limited to writing & medical review) within health regulatory timelines.
- Support managing Development Safety Update Reports (DSUR) related activities in collaboration with clinical safety team including development of safety strategy and safety management plan; partake in building safety strategy with internal and/or external stakeholders.
- Support and/or Train team members on assigned therapeutic areas/product portfolios, e.g., ophthalmic drugs.
2- Develop, review and update specific safety plans, as required, in liaison with PV operations team, Clinical development, regulatory affairs and other cross functional departments
- To represent company from clinical safety perspective in cross functional and/or oversight committee meetings effectively
3- Support and manage coordination of Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department) within timely manner.
4- Conduct Signal Management related activity (including signal detection by company methodology, medical review of signal reports, communication, and escalation to relevant signal boards).
5- Provide medical/safety inputs in the Product Information and labelling issues.
- Develop, update and maintain CCDS and/or RSI in line with product’s development phase
6- Health Authority Responses
- Assists in preparing and/or prepares responses to Regulatory Authority questions related to safety issues and conducts medical review
- Training of team members.
7- Liaise with internal and external stakeholders and Viatris drug safety in performance of the above-mentioned tasks.
8- Assists in any other Pharmacovigilance department projects such as SST Quality Management Systems, Clinical Overview Addendum(s), as necessary.
9- Provides medical safety expertise and training to other personnel, as necessary.
10- Keeps current with professional and pharmacovigilance regulations and knowledge.
11- Provides guidance to senior/drug safety technical assistants, senior/drug safety specialist and medical reviewers in various aspects of drug safety and any other Viatris personnel.
12- Writing & update of Standard Operating Procedures (SOP).
13- Escalating issues of importance and tracking until they are adequately resolved.
Qualification & Experience:
- Qualification: MD Ophthalmology/CPSC Ophthalmology/DNB (Post MBBS)
- Atleast 2-3 years of pharmaceutical industry experience, preferably working within pharmacovigilance.
- Knowledge of Pharmacovigilance guidance’s
