Pharmacovigilance Officer

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We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

• Manage the day-to-day country's Pharmacovigilance Systems in MEA and ensure local compliance with applicable Pharmacovigilance regulations and corporate policies (local and global).
• Lead Pharmacovigilance training at local and regional level (as applicable)
• Assist in signal detection activities regionally when appropriate.
• Manage intake, tracking and forwarding of Adverse Events and Special Situations concerning medicinal products, cosmetics, biocides, nutritional’s and medical devices (when registered locally/regionally as drugs) with or without Product Technical Complaint to Global Pharmacovigilance & Risk Management (GPRM)] or partner (as applicable); reconciliation activities and documentation of cases identified through spontaneous reporting, literature and all other potential sources to GPRM.
• Maintain the GPRM PSMF sections related to Medpharma-UAE MAH up to date (MEA).
• Manage case follow-up as required, including targeted questionnaires.
• Ensure provision oversight and support for external safety data processing service provider to ensure high quality and compliant individual case processing and reports.
• Ensure review and approve adverse event reports for post marketed products: ensure review of case narratives and co-ordinate with external service provider and internal medical personnel as required.
• Co-ordinate with internal stakeholders / regulatory designee(s) with expedited safety reports or aggregate reports for submission to the local health authorities for assigned territories, documentation thereof.
• Review of metrics for critical drug safety processes such as safety alert notifications to ensure compliance with company standard operating procedures (SOPs), applicable regulatory requirements and international guidelines.
• Contribute to continuous improvement local processes as required.
• Co-ordinate preparation activities in assigned territories for the support of and review periodic safety reports, aggregate reports (periodic Adverse Drug Events (ADE), Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Report (PBRER).
• Communication of identified safety issues to manager and or GPRM.
• Monitor PV data on country Health Authority websites and check for changes in local/regional regulatory environment, updating PV System accordingly. Notify GPRM of any changes which may affect global processes or the exchange of safety information within GPRM or with partners.
• Contribute to the development, revision and updating of local PV SOPs/Global/Regional SOPs to ensure compliance with the local regulatory agency requirements and regional PV SOPs.
• Assist in the development of training materials and conduct training to new hires, local affiliates on drug safety reporting to meet company SOPs, local and international laws and guidelines, as required.
• Assist in management of pharmacovigilance audits and inspections in region from external notified body, regulatory agencies, or corporate auditors. Notify GPRM PV Compliance Team and EEA QPPV of any Local/Regional Health Authority Inspections.
• Ensure support Direct Healthcare Professional communication, additional risk minimization measures (e.g., educational materials) and other risk minimization activities according to RMP (in cooperation with GPRM Risk Management Group), other departments and partner, as applicable.
• Ensure notification of Pharmacovigilance alerts in collaboration with GPRM and local hierarchy, as necessary.
• Participate in safety-related actions as requested from EU QPPV office.
• Track labelling update activities when received.
• Oversee management of CAPA related to any country inspections or audits.
• Ensure/perform/organize local literature search for adverse events/special situations of relevant local journals (not listed in EMBASE); maintain documentation of searches and ensure proper literature assessment.
• Inform GPRM, including EEA QPPV office of changes to local Responsible Persons/Deputy for MEA region.
• Ensure update of Company Product Dictionary (CPD) on a regular basis.
• Coordinate responses with GPRM related to requests from Health Authority.
• Represent GPRM and the company in an ethical and positive manner.
• Prepare, maintain, and review local SDEAs (country/ regional) in cooperation with GPRM Agreements Team.
  
  

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

Bausch Health is an EEO/AA employer M/F/D/V.