Pharmacovigilance Manager

Company: Baxter International Inc. –

WebSite: Riyadh, Saudi Arabia

Job Description:**Baxter: Pharmacovigilance Specialist – Middle East and Africa Region**

Baxter is dedicated to its mission of saving and sustaining lives through pioneering medical innovations. Our commitment to improving patient outcomes is reflected in our global presence, with products and therapies utilized in hospitals, clinics, and homes worldwide. As a member of Baxter, your contributions will directly impact the health and well-being of individuals globally.

The Safety Operations team is seeking a Pharmacovigilance (PV) Specialist to manage country-level PV activities, including the collection, documentation, and processing of local adverse event (AE) reports from all sources.

**Key Responsibilities:**

* Serve as the Saudi Arabian national Qualified Person for Pharmacovigilance (QPPV), fulfilling all requirements stipulated by local legislation. Act as the primary point of contact for pharmacovigilance matters within Saudi Arabia, interfacing with the competent authority and serving as the focal point for pharmacovigilance inspections.
* Serve as the Gulf Council Countries (GCC) QPPV and the single point of contact for pharmacovigilance matters 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 Middle East and Africa (MEA) Patient Safety team, function as the primary PV contact responsible for all pharmacovigilance activities in assigned countries within the Middle East, including but not limited to Saudi Arabia, Gulf, Levant, Iran, Pakistan, Afghanistan, etc.
* Act as the Baxter PV contact and manage all activities related to cooperation with vendors and distributors in assigned countries.
* Ensure compliance with pharmacovigilance legislation in Saudi Arabia, Arab League countries, and other Middle Eastern countries.
* Maintain a comprehensive understanding of the Baxter pharmacovigilance system, as described in the Pharmacovigilance System Master File (PSMF), and develop and maintain country-specific Pharmacovigilance Subsystem Files (PSSF/PVSF, etc.) based on the PSMF and local legislation.
* Collaborate with Global Patient Safety (GPS), the European Union Qualified Person for Pharmacovigilance (EU QPPV), and the regional CEEI&META Patient Safety Director to maintain an efficient PV system that adheres to regional, Arab League, and national regulations, as well as Baxter’s PV procedures.
* Remain informed of relevant national PV legislation in Saudi Arabia and assigned countries, including requirements for Individual Case Safety Report (ICSR) reporting, and promptly communicate any pertinent changes to the regional CEEI&META Patient Safety Director and the global patient safety team.
* Maintain appropriate communication with the country/region General Manager and other relevant interfaces, including country Regulatory Affairs, country Quality Assurance, business units, healthcare professionals, and Competent Authorities in Saudi Arabia and assigned countries.
* Work closely with the regional CEEI&META Patient Safety Director on all aspects of pharmacovigilance.
* Represent Baxter’s corporate expertise and opinions to local Competent Authorities.
* Support responses to pharmacovigilance-related inquiries or requests from Saudi Arabian, Middle Eastern, and other Competent Authorities, in close collaboration with the EU QPPV office and the regional CEEI&META Patient Safety Director.
* Escalate any safety-related issues arising in Saudi Arabia or other assigned countries to the regional CEEI&META Patient Safety Director, EU QPPV, and global patient safety team without delay.
* Conduct surveillance activities for new potential safety information (e.g., similar AEs reported in clusters or multiple cases for one batch received in a short time frame) and escalate findings according to established procedures.
* Be flexible as assignment of countries of responsibilities may change if required by business or pharmacovigilance needs.
* Identify, implement, and maintain local processes and documentation (procedures, instructions) to establish an efficient local pharmacovigilance system in Saudi Arabia and assigned countries, ensuring compliance with Competent Authorities’ and countries’ PV legislation and Baxter’s pharmacovigilance procedures.
* Contribute to the quality management system.
* Develop and maintain local PV system descriptions for assigned countries, as required by local legislation (e.g., PSSF).
* Maintain a thorough understanding of local PV legislation in the Middle East region and assigned countries.

**Specific Activities:**

* **Adverse Drug Reaction (ADR) Reporting:**
* Maintain awareness of and adherence to local reporting rules in Saudi Arabia, the Middle East, and assigned countries, communicating any changes immediately to the ECEMEA PV Director and the global team.
* Receive, document, follow-up (if needed with special forms), and register ICSRs and other reportable information from all sources in the global database, adhering to Baxter’s global procedures and timelines.
* Submit ICSRs to Saudi Arabian and assigned countries’ Competent Authorities in a timely manner and according to their specific requirements. Respond to subsequent inquiries from Competent Authorities in collaboration with the regional CEEI&META Patient Safety Director.
* Respond to inquiries from Healthcare Professionals, with support from the global patient safety team and in collaboration with the regional CEEI&META Patient Safety Director.
* Respond to inquiries and requests from the global patient safety team in a timely manner.
* Conduct searches of local journals in the Middle East region and assigned countries.
* **Training:**
* Provide pharmacovigilance training to new Baxter employees upon their arrival and to Baxter customer-facing employees on an annual basis or as required by local regulations.
* Train any third parties bound by safety agreements with Baxter in Saudi Arabia and assigned countries, with the agreed-upon frequency as specified in the agreements.
* Maintain awareness of and oversee safety agreements with Baxter partners in Saudi Arabia and assigned countries, ensuring the fulfillment of listed activities, including the exchange of ICSRs and periodic reconciliation.
* Review local SDEAs as per internal process.
* **Other Activities:**
* Contribute to the preparation and review of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Post-Authorization Safety Studies (PASS), signal detection, and PSP/MRPs.

**Qualifications:**

* Compliance with country requirements regarding the position of the local PV person.
* Proficiency in computer skills: Word, Excel, PowerPoint.
* Languages: Native language fluency and excellent proficiency in English.
* Strong communication skills.
* Bachelor’s degree in pharmacy or medicine.
* Minimum of 3 years of experience in pharmacovigilance.
* Knowledge of Saudi Arabian and Arab League pharmacovigilance legislation and guidelines.

**Reasonable Accommodations:**

Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require a reasonable accommodation for any part of the application or interview process due to a medical condition or disability, please contact us to discuss your needs.

**Recruitment Fraud Notice:**

Please be aware of recruitment fraud. Baxter has identified instances where fraudulent parties pose as Baxter employees or recruiters to steal personal and/or financial information. Please exercise caution and review our Recruitment Fraud Notice for information on how to protect yourself.

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