Senior Pharmacovigilance Specialist
Job Fit Check
Base Career helps you apply smarter for this job.
Key skills for this role
About the Role
Viatris seeks a Senior Pharmacovigilance Specialist to serve as local QPPV and Affiliate Safety Representative in Saudi Arabia. The role involves managing the PV system, ensuring compliance with local and global regulations, handling ICSRs, periodic safety reporting, training, audits, and safety data exchange.
Key Skills for This Role
Responsibilities
- Serve as local QPPV and Affiliate Safety Representative (ASR) for Viatris in KSA
- Organize, implement, and maintain the Affiliate PV System
- Ensure after hours availability as per local regulation
- Manage ICSR handling including receipt, documentation, forwarding, tracking, and follow up
- Ensure collection of safety data for interventional studies and company initiated programs
- Screen Viatris sponsored social media and local medical literature for safety information
- Ensure patient confidentiality and privacy
- Handle safety information including adverse events, product quality complaints, and safety communications
- Inform relevant global team about PSUR requirements and provide safety information
- Monitor affiliate PV system performance and compliance, report monthly metrics
- Maintain awareness of local and international PV legislation
- Ensure compliance with local agreements, including reconciliation and safety data exchange
Requirements
- Minimum of a Bachelor’s or master’s degree in medicine, Pharmacy, or Life Sciences (or equivalent)
- Saudi national
- Valid license from the Saudi Commission for Health Specialties (SCFHS)
- Completion of all mandatory PV trainings in accordance with SFDA requirements
- Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance
- Strong communication skills, excellent project management, team working, and organizational skills
- Able to operate internationally with fluent English
- Proficiency in computer skills
Full Job Posting
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.
- Follow up and lead implementation of PV requirements within distributors dealing with Viatris in the region.
Core Job Responsibilities
- ASR and Local QPPV: organize, implement, and maintain the Affiliate PV System.
- After Hours Availability: ensure after hours availability as per local regulation.
- ICSR handling: ensure local processes for ICSR management including receipt, documentation, forwarding, tracking, follow up.
- Ensure collection of safety data for interventional studies and company initiated programs.
- Screen Viatris sponsored social media and local medical literature for safety information.
- Ensure patient confidentiality and privacy.
- Handle safety information including adverse events, product quality complaints, and safety communications.
- Periodic Safety Reporting: inform global team about PSUR requirements and provide safety information.
- Compliance: monitor affiliate PV system performance, report monthly metrics, maintain awareness of legislation.
- Training: maintain training matrix, ensure basic PV training for new employees and refresher training.
- SOPs: ensure implementation of PV standards and procedures, develop local processes.
- Audits and Inspections: be key contact for internal audits and regulatory inspections.
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.
- Able to operate internationally with fluent English.
- Proficiency in computer skills.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Viatris
Head of Business Operations – MENA Eurasia
Dubai, UAE
Viatris is seeking a Head of Business Operations for MENA Eurasia to drive operational excellence, governance, and leadership development. The role requires 10-15+ years in pharmaceutical/healthcare, with at least 5 year
Head of Business Operations – MENA Eurasia
Media City, UAE
Viatris is seeking a Head of Business Operations for the MENA Eurasia region. This strategic leadership role drives operational excellence, governance, organizational effectiveness, and leadership development. Requires 1
Medical Representative - Dammam
Jeddah, KSA
Viatris seeks a Medical Representative for the Dammam territory to maximize sales of pharmaceutical products through physician visits and promotional activities. Requires a Bachelor's degree in Pharmacy, up to 3 years of
Regulatory Affairs Senior Manager
Saudi Arabia, KSA
Viatris seeks a Regulatory Affairs Senior Manager to lead and execute regulatory strategies for the KSA market. The role involves managing a team, ensuring compliance with local regulations, and liaising with global and
Regulatory Affairs Senior Manager
Riyadh, KSA
Viatris seeks a Regulatory Affairs Senior Manager to lead the KSA regulatory team, execute regulatory strategies, and ensure compliance for the Viatris portfolio. Requires 10+ years of regulatory affairs experience in hu
Senior Pharmacovigilance Specialist
Riyadh, KSA
Viatris seeks a Senior Pharmacovigilance Specialist in Riyadh to serve as local QPPV and Affiliate Safety Representative for KSA. Responsibilities include managing the PV system, ICSR handling, safety data collection, an
Regulatory Affairs Senior Manager
الرياض, KSA
Viatris is seeking a Regulatory Affairs Senior Manager to lead and manage regulatory activities for the KSA market. You will develop regulatory strategies, oversee submissions, manage a team, and liaise with stakeholders
Senior Pharmacovigilance Specialist
الرياض, KSA
Viatris seeks a Senior Pharmacovigilance Specialist to serve as local QPPV and Affiliate Safety Representative in Saudi Arabia. The role involves managing the pharmacovigilance system, ensuring compliance with local and
Head of Business Operations – MENA Eurasia
Dubai, UAE
Head of Business Operations – MENA Eurasia
Media City, UAE
Medical Representative - Dammam
Jeddah, KSA
Regulatory Affairs Senior Manager
Saudi Arabia, KSA
Regulatory Affairs Senior Manager
Riyadh, KSA
Senior Pharmacovigilance Specialist
Riyadh, KSA
Regulatory Affairs Senior Manager
الرياض, KSA
Senior Pharmacovigilance Specialist
الرياض, KSA