Senior PV Specialist - Gulf & Middle East, Viatris, Dubai, UAE

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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.  

 

The Senior PV Specialist is accountable for the managing, maintenance and continuous improvement of the Pharmacovigilance (PV) system for Viatris in country (including legal entities under Viatris). To ensure adherence to established local and Viatris Global processes and guidelines, adhering to national and international regulations and guidelines for pharmacovigilance.

The Senior PV Specialist is also responsible to lead and coordinate the PV team members in the country.

Key responsibilities:

ICSR handling

Ensures that local processes, procedures and systems are in place for Individual Case Safety

Report (ICSR) management including receipt, documentation, forwarding to PSRM PVOperations, tracking, follow up etc.

Ensure collection of safety data and other PV-related responsibilities in relation tointerventional studies (clinical trials)

Ensure collection of safety data and other PV-related responsibilities in relation to organized data collection schemes including, non-interventional studies, registries, customer engagement programs (CEPs) etc.

Ensures screening of Viatris-sponsored social media (web sites, web pages, blogs, vlogs, social networks, internet forums, chat rooms or health portals) for safety information.

Ensures screening of local language medical or scientific literature, not included in PSRMglobal iiterature review.

Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to.

Ensures handling of safety information

Periodic Safety Reporting

lnforms Safety Systems Team (SST) about the requirement/ change in requirement of any Periodic Safety Update.

Report (PSUR) in liaison with local regulatory affairs.

Provides safety information required for preparation of periodic safety report, upon request to SST.

Compliance

Ensures a local tracking system is in place, to ensure timely submissions of ICSRs to PV Operations.

Monitors Affiliate PV system performance and compliance. Reports monthly compliance metrics to Global PSRM.

Maintains awareness of local PV legislation and of relevant international legislations, regulations and guidelines.

Ensures tracking and communicating changes in local PV regulations that may have an impact on standards and procedures of Global PSRM.

Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.

Completes monthly ICSR reconciliation with interacting functions and/or departments, including medical information, product complaints.

Ensures functionality check of common PV mailboxes, phone numbers used for medical information/PV and fax number.

Ensures any changes to Affiliate PV personnel are communicated to the regulatory authority and relevant Global PSRM personnel in a timely fashion.

Ensures local deviation procedure is in place to document necessary planned departures from procedures and to be used when managing non-conformities.

arising from product complaints (in association withQA).

Training 

Maintains a version-controlled training matrix for local PV personnel.

Ensures basic PV training of new Affiliate employees and refresher training at least annually andthat appropriate training records are maintained.

Ensures relevant training of new PV staff.

Ensures training on and compliance to global and local SOPs, and relevant regulations and legislations.

Ensures that any training of partner company staff is completed according to local contract requirements and appropriately documented.

Creates PV training material where applicable and Approves PV Training material authored by others.

SOPs

Ensure implementation of PSRM standards and procedures, as applicable.

Ensures local processes and procedures are developed and implemented to define pharmacovigilance responsibilities in line with PSRM standards and procedures, as weIl as local regulations, as applicable.

Audits and Inspections

Be the key Affiliate contact for both internal PV audits and regulatory authority PV inspections.

Ensures that any regulatory authority communications are forwarded to the required PSRM personnel and that any corrective actions are completed according to schedule.

Safety Data Exchange (SDE) Agreements and other PV agreements

Ensures a local process is in place for management of local SDEAs and PV agreements that conforms to Viatris Standards per global procedures and local requirements.

Ensures that PV matters are appropriately considered during selection of service provider and in the contractual arrangements when subcontracting PV activities.

Risk Management Plan

Ensures local implementation and tracking of activities in accordance with Risk Management Plans (RMPs)

Safety inquiries

Ensures handling of inquiries relating to product safety including regulatory authority inquiries.

lnforms Regional Leads concerning urgent safety restrictions.

Safety Signals

lnforms SST about any potential signal or safety concern identified at local level.

PV business continuity

Ensures to planning of PV business continuity and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.

Archiving 

Ensures record retention of all PV related data and documents according to Viatris Global requirements and national requierments.

The minimum requirements for this role are:

Minimum a Medical, Pharmacy or Life-sciences Bachelor’s / Master’s degree (or equivaient).

Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.

Strong communicator.  Excelent project management skills, excellent team working skills, excellent organizational skills and capable of working efficiently in the local team as well as in other cross-functional teams. Able to operate internationally with fluent English.

Proficiency in computer skills, as required.

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. 

DETAILS TO REGISTER FOR THIS JOB:

https://viatris.wd5.myworkdayjobs.com/en-US/External/job/Media-City-Dubai-United-Arab-Emirates/Senior-PV-Specialist---Gulf---Middle-East_R5643024

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