Pv Manager

2 weeks ago

Dubai Media City, Dubai, United Arab Emirates Viatris Full time
VIATRIS MIDDLE EAST FZ-LLC

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 PV Manager - Gulf & Middle East role will make an impact:

Summary:
The Manager supervises the country as determined by the Regional Manager, PSRM. He/she is responsible to maintain oversight on the local affiliate PV-system and local regulatory obligations.

He/she ensures that affiliate PV-system is seamlessly connected with Global PSRM functions and is in compliance with local regulatory obligations, global processes and company standards.


Key responsibilities for this role include:

  • For ASR which are PSRM HC in the country and reporting to Manager: Define annual objectives proportionate to the extent ASR work on PV, Perform mid-year review of leadership competencies and annual objectives, Perform end-year evaluation of leadership competencies, annual objectives and overall rating, Have a lead role in determination of annual bonus and merit increase, Have a lead role in determining development needs and agreeing on measures of how to address those.
  • For ASR which are not PSRM HC and do not have a reporting line into the Manager because they are primarily assigned to a nonPV function, agree with the primary manager on PV annual objectives proportionate to the extent ASRs work on PV and contribute to the endyear evaluation. Further, ensure alignment with the primary function (e.g. RA) about the % of time allocation to PSRM and the fact that the primary function (e.g. RA) has the HC in its budget and must cover expenses related to PV as well.
  • Participate in interviews and decisionmaking regarding recruitment of ASR and facilitate onboarding of new ASR.
  • Ensure that ASR and local PVsystem are connected with all Global PSRMfunctions.
  • Key contact point for ASR queries on local/global processes, providing adhoc advice/comment.
  • Have regular 1on1s with all PV team members to understand/discuss: Leadership competencies and performance of all local PVstaff members, Issues with individual PVstaff members, Overall workload and deliverables, Resource needs, Local PVvendors, Local commercial partnerships (PVApartners), Local compliance, Challenges and issues.
  • Ensure the information is up to date in the Global Factsbook.
  • Review and approve affiliate SOPs and Business Continuity Plans (BCP).
  • Lead and support ASRs before, during and after audits/inspections, including CAPA development and review.
  • Ensure that Affiliate PVteams comply with global processes.
  • Followup on instances of noncompliance are addressed appropriately and closedout.


The role will assist in maintenance of company and legislative standards for pharmacovigilance and will drive to high levels of compliance in the concerned country.


  • Application and maintenance of consistent standards for PV across at the Affiliate.
  • Adherence to global and local SOPs.
  • Appropriate and adequate training for ASR.
  • Timely identification and appropriate response to areas of noncompliance.
  • Audit and inspection readiness at Affiliate at all times.
  • Realtime response to ASR questions.
  • Escalation of noncompliance to the Regional Manager/Lead.

The minimum qualifications for this role are:

  • Graduate with a Life Sciences or Pharmacy degree.
  • Computer literacy (Windows, MS Office).
  • Fluency in English language.
  • At least eight years' experience in Pharmacovigilance in the pharmaceutical industry.
  • Knowledge of national pharmacovigilance regulation of the particular country.
  • The ability to give attention to detail.
  • A track record of commitment to quality is essential.
  • Flexible and proactive.
  • Willingness for business travel (up to 10% of working time).


At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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