VIATRIS ARABIA LIMITED "LLC"
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Primary Job Function:
Primary role as local QPPV for Viatris in KSA.
As Affiliate Safety Representative (ASR), accountable for the execution, maintenance, and continuous improvement of the Pharmacovigilance (PV) system for Viatris in Saudi Arabia (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.
Follow up and lead implementation of PV requirements within distributers dealing with Viatris in the region, to assure they meet Viatris required qualifications, through executing training programs and scheduled follow ups
Core Job Responsibilities:
ASRandLocal QPPV
AsASRandlocalQPPV,isresponsibletoorganize,implement,andmaintaintheAffiliatePV System.
After -Hours Availability
Ensureafter-hoursavailabilityas perlocal regulation.
ICSR handling
Ensures that local processes, procedures, and systems are in place for Individual Case Safety Report(ICSR)managementincludingreceipt,documentation,forwardingtorelevant global team,tracking, follow up etc.
EnsurecollectionofsafetydataandotherPV-relatedresponsibilitiesinrelationtointerventional studies (clinical trials)
Ensurecollectionofsafetydataandfulfillment of otherPV-relatedresponsibilitiesinrelationtoCompany-initiated Epidemiological Programs (CEPs) including PSPs, MRPs, registries, non-interventional studies, 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 is performed and reconciliation is in place as per required.
Ensures screening of local medical or scientific literature and ensure proper translation if needed, for medical/ scientific journals are not included in global literature review.
Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to.
Ensureshandlingofsafety information including adverse event reports, product quality complaints (PQCs), and safety communications, received from internal teams, healthcare professionals, regulatory authorities, or other relevant sources.
PeriodicSafety Reporting
Informrelevant global teamabouttherequirement/changeinrequirementofanyPeriodic Safety Update Report (PSUR) in liaison with local regulatory affairs.
Provides safety information required for scheduling and preparation of periodic safety report, upon request to relevant global team
Compliance
MonitorsAffiliatePVsystemperformanceandcompliance.Reportsmonthlycompliancemetrics to relevant global team
MaintainsawarenessoflocalPVlegislationandofrelevantinternationallegislations,regulations, and guidelines.
EnsurestrackingandcommunicatingchangesinlocalPVregulationsthatmayhaveanimpacton global standards and procedures.
Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
CompletesmonthlyICSRreconciliationwithregional stakeholders,including medical information and product complaints.
Ensures deviation procedure is in place to document necessary planned deviations from proceduresandtobeusedwhenmanagingnon-conformitiesarisingfromproductcomplaints(in association with QA).
Training
Maintainsaversion-controlledtrainingmatrixforlocalPV personnel.
EnsuresbasicPVtrainingofnewAffiliateemployeesandrefreshertrainingat least annuallyand that appropriate training records are maintained.
EnsurestrainingonandcompliancewithglobalandlocalSOPs,andrelevantregulationsand legislations.
Ensurethatanytrainingofpartnercompanystaffiscompletedaccordingtolocalcontract requirements and appropriately documented.
Creates PV training material where applicable and approves PV Training material authored by others.
SOPs
Ensure implementation of PV standards and procedures, as applicable.
Ensures local processes and procedures are developed and implemented to define PV responsibilities in line with global standards and procedures, as weIl as local regulations, as applicable.
Auditsand Inspections
BethekeyAffiliatecontactforbothinternalPVauditsandregulatoryauthorityPV inspections.
Ensurethatanyregulatoryauthoritycommunicationsareforwardedtotherequiredrelevant global teamand that any corrective actions are completed according to schedule.
Ensure that affiliate PV system is in audit/inspection readiness.
SafetyDataExchange(SDE)AgreementsandotherPV agreements
Ensurescompliance with managementoflocalSDEAsandPVagreements, in alignment withglobal standards, procedures, and local requirements.
EnsuresthatPVmattersareappropriatelyconsideredduringselectionofserviceproviderandin the contractual arrangements when subcontracting PV activities.
RiskManagement Plan
Ensures local implementation and tracking of activities in accordance with Risk ManagementPlans (RMPs)
Safety inquiries
Ensureshandlingofinquiriesrelatingtoproductsafetyincludingregulatoryauthority inquiries.
Safety Signals
Informrelevant global teamaboutanypotentialsignalorsafetyconcernidentifiedatlocal level.
PVbusiness continuity
EnsurePVbusinesscontinuity plan andnotificationofanybusinessinterruptionsthat pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
Perform annual BCP testing and ensure proper documentation.
PSSF
ForwardsanyregulatoryauthorityrequesttoprovidethePSSFtorelevantglobal teams
Execute, maintain and submitnecessaryupdatesofthePSSFwithinthestipulatedtimeline,inaccordancewithViatris global process.
Archiving
Ensures record retention of all PV related data and documents according to Viatris global requirements and national requirements.
Supervisory / Management Responsibilities:
☐Yes ☒No
Minimum Education/ mandatory requirements:
Minimum of a Bachelor’s or master’s degree in medicine, Pharmacy, or Life Sciences (or an equivalent qualification).
Saudi national.
Valid license from the Saudi Commission for Health Specialties (SCFHS).
Completion of all mandatory PV trainings in accordance with Saudi Food and Drug Authority (SFDA) requirements, obtained through a SFDA recognized training provider.
Minimum Experience / Training Required:
Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.
Strong communication skills.Excellent 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.
A t Viatris, we offer competitive salaries, benefitsandan 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.
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale. In 2022 alone, we supplied high-quality medicines to approximately 1 billion patients around the world. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. We have the ability to touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India
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