Regional Pharmacovigilance Manager

Our Client, a multinational pharmaceutical company, is looking for a Regional Pharmacovigilance Manager to join their ever-growing team in Riyadh.

A suitable candidate will be a fluent Arabic & English speaker with a Pharmacist degree.

This role is for Saudi Nationals only.

Job Overview

• Acting as Saudi Arabian national QPPV as required by local legislation and a single pharmacovigilance contact point in Saudi Arabia towards the competent authority and also as a contact point for pharmacovigilance inspections.

• Acting as GCC QPPV and a single pharmacovigilance contact point as accepted by competent authorities and required by local legislation in Gulf and Levant countries towards the appropriate competent authorities (CAs) in those countries and also as a contact point for pharmacovigilance inspections.

• Within the frames of the Middle East and Africa PV team acting as the primary PV local contact responsible for all pharmacovigilance activities for assigned countries of responsibility in the Middle East, including but not limited to: Saudi Arabia, Gulf, Levant, Iran, Pakistan, Afghanistan, etc.

• Within the frames of the Middle East and Africa PV team acting as PV backup contact responsible for all pharmacovigilance activities that may be needed to perform during the backing up period in assigned African countries, including but not limited to Egypt, Tunisia, South Africa, etc.

• To act as the company’s PV contact for and to manage all needed activities connected to cooperation with vendors and distributors from assigned countries of responsibility.

• To fulfil the requirements of the Saudi Arabian PV, Arab League countries, and other Middle East countries’ legislation for pharmacovigilance.

• Have an overview of the company’s pharmacovigilance system described in the Pharmacovigilance System Master File and, based on it and local legislation, create and maintain other pharmacovigilance systems described as Pharmacovigilance Subsystem Files (PSSF/PVSF, etc.) for assigned countries.

• Collaborate with GPS, EU QPPV, and ECEMEA PV director to maintain an efficient PV system meeting regional, Arab League, and national regulations and in compliance with internal PV procedures.

• To keep awareness and being updated on relevant national Saudi Arabian and assigned countries’ PV legislation, including requirement for reporting of ICSRs, and inform ECEMEA PV director and global patient safety team about any relevant changes to the PV legislation.

• Ensure appropriate contact with the country/region general manager and other interfaces not limited to country regulatory affairs, country quality assurance, business units, and with healthcare professionals and CAs in Saudi Arabia and assigned countries.

• Working closely with ECEMEA PV director in each pharmacovigilance aspect.

• Outlining and representing the company’s corporate expertise and opinion towards local CAs.

• Support answering questions or requests related to pharmacovigilance from Saudi Arabian, Middle East, and other CAs in close collaboration with EUQPPV office and ECEMEA PV director.

• Escalate to EMEA PV head, ECEMEA PV Director, EUQPPV, and global patient safety any safety-related issues that arise in Saudi Arabia or other assigned countries without delay.

• Performing surveillance activities for any new potential safety information (e.g., similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalating as per procedures.

• To be a member of the local pharma association and actively participate in meetings, if applicable.

• Assignment of countries of responsibilities may change if required by business or pharmacovigilance needs.

Essential Duties & Responsibilities

• Identifying, implementing, and maintaining local processes and documents (procedures, instructions), building an efficient local pharmacovigilance system in Saudi Arabia and assigned countries, meeting CAs’ and countries’ PV legislation requirements, and being in compliance with internal pharmacovigilance procedures.

• Contribution to the quality management system.

• Creation and maintenance of local PV systems description in assigned countries as required per local legislation e.g., PSSF.

• Awareness of local reporting rules in Saudi Arabia and assigned countries, changes to them, and immediately informing ECEMEA PV director and global team about these requirements.

• Receipt of ICSRs and any other reportable information from any source, documentation, follow-up (if needed with special forms) and registration in the global database in accordance with global procedures and within timelines.

• Submission of ICSRs to Saudi Arabian and assigned countries’ CAs timely and according to their requirements. Answering subsequent questions from CAs in collaboration with ECEMEA cluster head.

• Answering questions from HCPs with support or global patient safety and in collaboration with ECEMEA cluster head.

• Answering questions and requests from global patient safety in a timely manner.

• Training on PV of new employees upon their arrival and customer-facing employees on a yearly basis or as needed by local regulations.

• Train on PV any third parties bound with the company with safety agreements in Saudi Arabia and assigned countries with agreed frequency as indicated in the agreement.

• Archive training documentation.

• Keep up-to-date own training records.

• Awareness, an overview of safety agreements with the company’s partners in Saudi Arabia and assigned countries, and fulfillment of listed activities including but not limited to the exchange of ICSRs and periodic reconciliation.

• Review of local SDEAs as per internal process.

• Having overview and access to the current local PSUR schedule from regulatory affairs.

• If needed and according to an established local process, validate the comparative table prepared by regulatory in order to put CCDS/CCSI/RSI and local SmPC in conformity.

• Awareness, an overview of, and review of safety sections local PSP/MRPs, RMPs, PASS-protocols, and fulfillment of specified activities if applicable locally, for example, risk minimization measures to be implemented locally.

• Ensure appropriate contact with the country/region general manager and other interfaces not limited to countries’ regulatory affairs, quality assurance, business units, and with healthcare professionals and CAs in Saudi Arabia and assigned countries.

• Bringing safety expertise and advice to other local functions when needed.

• Review local safety communications.

• Participation in all safety issues with products in Saudi Arabia and assigned countries, emerging safety concerns, and safety variations.

• Act as a contact point for inspections in Saudi Arabia and assigned countries. Participation in internal audits as per plan.

• Monitor and ensure local compliance, and make efforts to achieve high compliance rates.

• Participation in CAPA, initiation, and FU of CAPA.

• Being part of the MEA PV team on a daily basis and part of ECEMEA PV team and providing it with needed support.

• Provide support to MEA countries in different aspects of pharmacovigilance as requested.

• Providing PV back-up for the national QPPV/LSR/primary PV contact in assigned countries, including receipt of AE reports from any external/internal sources, case intake, submission to local MOH and Partners where required (i.e., by checking OST on daily bases and performing submissions within deadlines).

• Performing quality check of cases in which intake was performed by primary PV contact.

• Travelling to countries assigned as national QPPV/LSR/primary contact and other MEA countries according to pharmacovigilance and business needs.

Qualifications & Skills

• Saudi National is a must.

• Excellent Arabic and English skills.

• Minimum bachelor’s degree in pharmacy.

• Experienced in Pharmacovigilance for at least 3 years.

• Min. 2 years of managerial experience.

• Knowledge of Saudi Arabian and Arab League pharmacovigilance legislation and guidelines.

• Compliance with country-specific requirements.


Regional Pharmacovigilance Manager - Riyadh, Saudi Arabia - Agnieszka Bednarz

DNA consultant in charge of this requisition:

Agnieszka Bednarz

CEEMEA Senior Research Consultant

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

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