Sr, Pharmacovigilance Specialist

This is where you save and sustain lives
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Baxter, your work makes a positive impact on people around the world. You'll
feel a sense of purpose throughout the organization, as we know our work
improves outcomes for millions of patients.
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in clinics and in the home. For over ‎85 years, we have pioneered significant
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Together, we create a place where we are happy, successful and inspire each
other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives --where your
purpose accelerates our mission.
Local PV system
* Identifying, implementing and maintaining local processes and documents (procedures, instructions) building an efficient local pharmacovigilance system in Egypt and assigned countries, meeting CAs ' and countries' PV legislation requirements and in compliance with Baxter pharmacovigilance procedures.
* Contribution to quality management system.
* Reviewing and updates to Baxter PSMF.
* Preparation, maintenace and approval of PSSFs in assigned countries as required by local legislation.
ADR reporting
* Awarness of local reporting rules in Egypt and assigned countries, changes to them, and immediate informing ECEMEA PV head and global team about this 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 Egyptian 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 request from Global Patient Safety (GPS) in timely manner.
Training
* 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 Egypt and assigned countries with agreed frequency as indicated in agreement.
* Archive training documentation.
* Keep up to date own training records.
Safety agreements
* Awarness, overview of safety agreement with Baxter partners in Egypt and assigned countries and fulfilment of specified activities including but not limited to exchange of ICSRs and periodic reconciliation.
* Review of local SDEAs as per internal process.
PSURs, RMPs, PASS, PSP/MRPs
* Having overview and access to current local PSUR schedule from regulatory affairs.
* If needed and according to established local process validate comparative table prepared by regulatory in order to put CCDS/CCSI/RSI and local SmPC in conformity.
* Awarness, overview of and review of safety sections local PSP/MRPs, RMPs, PASS-protocols and fulfilment of specified activities if applicable locally for example risk minimization measures to be implemented locally.
Interactions
* Ensure appropriate contact with country/region general manager and other interfaces not limited to countries ' regulatory affairs, quality assurance, business units and with healthcare professionals and competent authorities in Egypt and assigned countries.
* Bringing safety expertise and advice to other local functions when needed.
Local safety issues
* Review local safety communications.
* Participation in all safety issues with products in Egypt and assigned countries, emerging safety concerns, safety variations.
Audits and inspections
* Act as contact point for inspections in Egypt and assigned countries. Participation in internal audits as per plan.
Compliance
* Monitor and ensuring local compliance, make efforts to achieve high compliance rates.
* Participation in CAPA, initiation and FU of CAPA.
Activities related to other countries in MEA region:
* Being part of MEA PV team.
* 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 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.
ECEMEA PV team
* Being part of ECEMEA PV team and provide it with needed support.
BAXTER
* Supporting training assignments in Baxter 's global training system (BAXU) in partnership with GPS managers and HR.
* Supporting upcoming inspections and audits with questions related to GPS training and presenting GPS training standards.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to
individuals with disabilities. If, because of a medical condition or
disability, you need a reasonable accommodation for any part of the
application or interview process, please send an e-mail to
[email protected] and let us know the nature of your request along with
your contact information.
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