Senior Pharmacovigilance Specialist
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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 pharmacovigilance system, ensuring compliance with local and global regulations, handling ICSRs, training, audits, and safety data exchange.
Key Skills for This Role
Responsibilities
- Serve as local QPPV for Viatris in KSA
- Act as Affiliate Safety Representative, accountable for execution, maintenance, and continuous improvement of the PV system
- Ensure after hours availability as per local regulation
- Manage ICSR handling including receipt, documentation, forwarding, tracking, follow up
- Ensure collection of safety data for interventional studies and company initiated epidemiological programs
- Screen Viatris sponsored social media and local medical literature for safety information
- Monitor affiliate PV system performance and compliance, report monthly metrics
- Maintain training matrix and ensure PV training for affiliate employees and partner company staff
- Be key affiliate contact for internal PV audits and regulatory authority PV inspections
- Ensure compliance with local SDEAs and PV agreements
Requirements
- Minimum of a Bachelor’s or master’s degree in medicine, Pharmacy, or Life Sciences
- 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 skills, excellent team working skills, excellent 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
- As ASR and local QPPV, is responsible to organize, implement, and maintain the Affiliate PV System.
- Ensure after hours availability as per local regulation.
- Ensure local processes for ICSR management including receipt, documentation, forwarding, tracking, follow up.
- Ensure collection of safety data for interventional studies and company initiated epidemiological programs.
- Screen Viatris sponsored social media and local medical literature for safety information.
- Ensure patient confidentiality and privacy.
- Handle safety information including adverse event reports, product quality complaints, and safety communications.
- Inform relevant global team about PSUR requirements.
- Monitor affiliate PV system performance and compliance, report monthly metrics.
- Maintain awareness of local PV legislation.
- Ensure tracking and communicating changes in local PV regulations.
- Maintain compliance with local agreements, including reconciliation and safety data exchange.
Minimum Education / Mandatory Requirements
- Minimum of a Bachelor’s or master’s degree in medicine, Pharmacy, or Life Sciences.
- Saudi national.
- Valid license from the Saudi Commission for Health Specialties (SCFHS).
- Completion of all mandatory PV trainings in accordance with 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.
About Viatris
- Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands.
- We provide access at scale, currently supplying high quality medicines to approximately 1 billion patients worldwide annually.
- Viatris is an Equal Opportunity Employer.
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