Pharmacovigilance Manager

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Summary

This position is a member of the Safety Operations team that handles country level PV activities including collection, documentation and processing of local adverse event (AE) reports from all sources.

• Act 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 Gulf Council Countries (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 Middle East and Africa (MEA) PS team acting as primary PV local contact responsible for all pharmacovigilance activities for assigned countries of responsibility in Middle East including but not limited to Saudi Arabia, Gulf, Levant, Iran, Pakistan, Afghanistan etc.

• To act as Baxter 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 overview of Baxter pharmacovigilance system described in Pharmacovigilance System Master File (PSMF) 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 regional CEEI&META PS director to maintain an efficient PV system meeting regional, Arab League and national regulations and in compliance with Baxter’s 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 regional CEEI&META PS director and global patient safety team about any relevant changes to the PV legislation.

• Ensure appropriate contact with 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 regional CEEI&META PS director in each pharmacovigilance aspect.

• Outlining and representing Baxter 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 regional CEEI&META PS director.

• Escalate to regional CEEI&META PS Director, EUQPPV and global patient safety any safety related issues arisen 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 escalate as per procedures.

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

• 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 Baxter pharmacovigilance procedures.

• Contribution to quality management system.

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

• Knowledge of local PV legislation in Middle East region and assigned countries.

• ADR reporting

• Awareness of local reporting rules in Saudi Arabia, Middle East and assigned countries, changes to them, and immediate 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 global database in accordance with global Baxter 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 regional CEEI&META PS director.

• Answering questions from HCPs with support or global patient safety and in collaboration with regional CEEI&META PS director.

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

• Searching of local journals in Middle East region and assigned countries.

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

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

• Awareness, overview of safety agreement with Baxter partners in Saudi Arabia and assigned countries and fulfilment of listed activities including but not limited to exchange of ICSRs and periodic reconciliation.

• Review of local SDEAs as per internal process.

• PSURs, RMPs, PASS, Signals, PSP/MRPs.

Requirements

• Compliance with country requirements regarding position of local PV person.

• Computer skills: Word, Excel, PowerPoint.

• Languages: Mother tongue - excellent; English – excellent/very good.

• Communications skills.

• Bachelor’s degree in pharmacy or medicine,

• Experience in Pharmacovigilance (at least 3 years)

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

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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