Senior Pharmacovigilance Specialist

This is a fully remote position, open to applicants in Ukraine, +5 more countries.

📋 Description

• Maintain and consistently update the GTEM-7 audit tracking file, ensuring the precise and timely entry of all information.

• Track audit observations, CAPA details, owners, due dates, status updates, and supporting documentation in the Internal file excel (i.e. audit coordinator assignment tracker).

• Enter sanctioned audit observations and CAPA actions into the Global QMS, ensuring accurate documentation and prompt workflow initiation.

• Initiate and manage approved CAPAs administratively in the Global QMS, including tracking assignments, monitoring target due dates, and following up on workflows.

• Communicate with CAPA owners to obtain necessary supporting evidence and agreed-upon deliverables within specified timelines.

• Gather and consolidate supporting evidence packages from CAPA owners for Quality Oversight review by GPRM AUDIT coordinators.

• Monitor outstanding CAPAs and audit observations, proactively pursuing overdue deliverables and pending evidence.

• Conduct administrative completeness checks on received documentation (i.e. deliverables) prior to routing packages for final Quality review.

• Prepare and maintain trackers for pending evidence, overdue actions, and upcoming due dates to facilitate oversight activities.

• Coordinate the collection of necessary deliverables from CAPA OWNERS (i.e. vendors/partners/affiliates, GPRM SMEs) related to audit commitments and CAPA implementation.

• Assist in the preparation, compilation, and maintenance of PSMF Annex G1 and PSMF Module 7 documentation.

• Issue audit notifications to vendors/partners/affiliates following the approval of the audit schedule and liaise with functional heads regarding the audit report and initial notification to the auditee concerning the CAPA plan.

• Distribute Pharmacovigilance questionnaires and monitor the receipt of completed questionnaires.

• Prepare regular status reports on open observations related to ongoing CAPA Plans and the current status of the CAPA plans.

⛳️ Requirements

• A degree in Pharmacy or a background in life sciences.

• Excellent written and verbal communication skills in English.

• A minimum of 1 year of experience in Pharmacovigilance (PV).

• Experience in pharmaceutical companies is a plus.

• Familiarity with audit and CAPA management is advantageous.

• Exposure to the healthcare/life sciences industry is beneficial.

• Exceptional analytical and quantitative problem-solving abilities.

• Well-organized with a keen attention to detail.

• Capability to work under pressure and meet urgent deadlines.

• Strong planning and reporting skills.

• Proven track record of innovative thinking.

• Ability to develop and interpret policies while managing multiple tasks.

• Capacity to collaborate with others to resolve issues.

🏝️ Benefits

• Comprehensive health insurance plan.

• Opportunities for professional development and training.

• Flexible working hours and the possibility of remote work.

• Supportive and collaborative work environment.