Senior Pharmacovigilance Specialist

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• Maintain and continuously update the GTEM-7 audit tracking file, ensuring accurate and timely entry of all information • Track into the Internal file excel (i.e. audit coordinator assignment tracker) audit observations, CAPA details, owners, due dates, status updates, and supporting information. • Enter approved audit observations and CAPA actions into Global QMS, ensuring accurate documentation and timely workflow initiation. • Launch and administratively manage approved CAPAs in the Global QMS, including assignment tracking, target due date monitoring, and workflow follow-up. • Communicate with CAPA owners to obtain required supporting evidence and agreed deliverables within target timelines. • Collect and consolidate supporting evidence packages received from CAPA owners for Quality Oversight review by GPRM AUDIT coordinators. • Monitor open CAPAs and audit observations, proactively chasing overdue deliverables and pending evidence. • Perform administrative completeness checks of received documentation (i.e deliverables) before routing packages for final Quality review. • Prepare and maintain trackers of pending evidence, overdue actions, and upcoming due dates to support oversight activities. • Coordinate collection of required deliverables from CAPA OWNERS (i.e. vendors/partner/affiliate, GPRM SME) related to audit commitments and CAPA implementation. • Support the preparation, compilation, and maintenance of PSMF Annex G1 and PSMF Module 7 documentation. • Issue audit notifications to vendors/partner/affiliate following approval of the audit schedule and communicate with functional heads regarding audit report and first notification to auditee regarding CAPA plan • Distribute Pharmacovigilance questionnaires and track receipt of completed questionnaires. • Prepare periodic status reports on open observations related to ongoing CAPA Plans and the status of the CAPA plans.

🎯 Requirements

• A Pharmacy degree or life science background. • Excellent written and oral communication skills in English. • At least 1 year PV experience. • Experience in pharmaceutical companies is an advantage. • Experience in audit and CAPA management is an advantage • Exposure to healthcare/life-sciences industry is an advantage. • Exceptional analytical and quantitative problem-solving skills. • Well-organized personality with attention to details. • Ability to work under pressure and urgent deadlines. • Strong planning and reporting skills. • Demonstrated track record of innovative thinking. • Ability to develop and interpret policies and to perform multiple tasks. • Ability to cooperate with others to solve problems.