Qualified Person for Pharmacovigilance

6 months ago

Riyadh, 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:
1. Availability 24/7 and residing in KSA
2. 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.
3. Have access to RAY PSMF and performing its updates and have sufficient authority to ensure its compliance to the regulations
4. Ensuring the necessary quality, including the correctness and completeness of the pharmacovigilance data submitted to the SFDA
5. 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
6. Perform regular Reconciliation with the concerned departments in the contracting MAHs or internally with other RAY departments
7. Management of safety and product complaints reports received by patient support programs, Reconciliation and quality check
8. Handling medical information requests and product defects either associated with AE or not about the contracting MAHs’ products
9. 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
10. Review and manage safety communication for the concerned audience
11. 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);
12. Help contracting MAHs’ regulatory personnel in preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines
13. 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.
14. 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)
15. Has oversight over SDEAs with partners and PV database operations and its validation
16. 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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