Qualified Person for Pharmacovigilance

2 weeks ago


Riyadh, Ar Riyāḑ, Saudi Arabia Ray Full time

Job Requirements:
1-Bachelor Degree of Pharmacy or Medicine.

2-Saudi Nationality

3-Basic training in epidemiology and biostatics and should be licensed by Saudi commission for health specialties

4-Previous Experience in the Pharmacovigilance duties and local PV regulations is required

Job Responsibilities:

  • Availability 24/7 and residing in KSA
  • Serves as Point of contact for the Regulatory authorities on behalf of the contracting MAH and responding promptly to any request from the regulatory authorities.
  • Have access to RAY PSMF and performing its updates and have sufficient authority to ensure its compliance to the regulations
  • Ensuring the necessary quality, including the correctness and completeness of the pharmacovigilance data submitted to the SFDA
  • Handle and process as applicable all spontaneous and solicited safety reports as ICSRs for contracting MAHs and regulatory obligations and submitting them as per regulatory timelines
  • Perform regular Reconciliation with the concerned departments in the contracting MAHs or internally with other RAY departments
  • Management of safety and product complaints reports received by patient support programs, Reconciliation and quality check
  • Handling medical information requests and product defects either associated with AE or not about the contracting MAHs' products
  • Manage preparation and Submission of PBRERs and their national appendix and addendum to clinical overview, as applicable, according to the regulatory obligations and timelines for contracting MAHs' products
  • Review and manage safety communication for the concerned audience
  • Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
  • Help contracting MAHs' regulatory personnel in preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines
  • Prepare for audits/inspections from regulatory authorities or contracted MAH in the department or internal audits for the department to ensure compliance with company and regulatory obligation.
  • Interact with different contracting MAH's Departments as applicable for integrating PV system (eg. Medical Information, Regulatory Affairs, Product Quality, Clinical Development, Sales and Marketing, Patient support Programs and Quality Assurance)
  • Has oversight over SDEAs with partners and PV database operations and its validation
  • Responsible for regulatory intelligence of the PV regulations in requested countries

Job Types:
Full-time, Contract

Ability to commute/relocate:

  • Riyadh: Reliably commute or planning to relocate before starting work (required)


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