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.