Senior Pharmacovigilance Specialist

Viatris Arabia Limited "Llc"

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

**ASR****and****Local****QPPV**

• As ASR and local QPPV, is responsible to organize, implement, and maintain the Affiliate PV System.
• **After****-Hours** **Availability**
• Ensure after-hours availability as per local regulation.

**ICSR****handling**

• Ensures that local processes, procedures, and systems are in place for Individual Case Safety Report (ICSR) management including receipt, documentation, forwarding to relevant global team, tracking, follow up etc.
• Ensure collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials)
• Ensure collection of safety data and fulfillment of other PV-related responsibilities in relation to Company-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.
• Ensures handling of safety information including adverse event reports, product quality complaints (PQCs), and safety communications, received from internal teams, healthcare professionals, regulatory authorities, or other relevant sources.

**Periodic****Safety****Reporting**

• Inform relevant global team about the requirement/ change in requirement of any Periodic 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

• Monitors Affiliate PV system performance and compliance. Reports monthly compliance metrics to relevant global team .
• 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 global standards and procedures.
• Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
• Completes monthly ICSR reconciliation with regional stakeholders, including medical information and product complaints.
• Ensures deviation procedure is in place to document necessary planned deviations from procedures and to be used when managing non-conformities arising from product complaints (in association with QA).

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 and that appropriate training records are maintained.
• Ensures training on and compliance with global and local SOPs, and relevant regulations and legislations.
• Ensure 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 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.

**Audits****and****Inspections**

• Be the key Affiliate contact for both internal PV audits and regulatory authority PV inspections.
• Ensure that any regulatory authority communications are forwarded to the required relevant global team and that any corrective actions are completed according to schedule.
• Ensure that affiliate PV system is in audit/inspection readiness.
• **Safety****Data****Exchange****(SDE)****Agreements****and****other****PV****agreements**
• Ensures compliance with management of local SDEAs and PV agreements, in alignment with global standards, 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.

**Safety****Signals**

• Inform relevant global team about any potential signal or safety concern identified at local level.

**PV****business****continuity**

• Ensure PV business continuity plan and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
• Perform annual BCP testing and ensure proper documentation.

PSSF

• Forwards any regulatory authority request to provide the PSSF to relevant global teams.
• Execute, maintain and submit necessary updates of the PSSF within the stipulated timeline, in accordance with Viatris 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

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.
• 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.