Senior Pharmacovigilance Specialist

Delta PV, a leading pharmacovigilance service provider headquartered in Istanbul, Türkiye, has been part of the Biomapas group since 1 August 2025. As such, this vacancy is advertised on behalf of Delta PV within the Biomapas organization.

We are looking for Senior Pharmacovigilance Specialists (Senior PVS) who will be responsible for an international pharmaceutical company for global operational delivery for assigned tasks on the project level. Senior PVS will act as the employee of international pharma company for the projected.  The person will report to Pharmacovigilance Manager of international company and there will be responsibilities under audit and CAPA management.  This role provides operational and administrative coordination for Pharmacovigilance audit, CAPA, KPI management, SDEA management and PV Intelligence activities.  Final quality assessment, CAPA approval, effectiveness review, and CAPA closure remain under the responsibility of the Quality Oversight team.

Responsibilities

• Maintain and continuously update the audit tracking file, ensuring accurate and timely entry of all information
• Track into the Internal file excel, 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 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 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.
• Support the Safety Data Exchange Agreement (SDEA) Process for global team and maintain trackers of activities.

Key Performance Indicators (KPIs)

• Maintain and regularly update submission compliance trackers in line with confirmed late case details
• Maintain the details of the amendment submissions
• Track and follow up on pending late case investigations, including timely reminders to relevant stakeholders
• Perform periodic KPI reconciliation with vendors and document outcome
• Conduct QC review of ICSR timeliness deviation memo
• Archiving the deviation memos

Pharmacovigilance (PV) Intelligence

• Distribute monthly PV newsletters and weekly PV safety alerts to designated recipients
• Monitor and follow up on responses to distributed PV alerts
• Track completion status of impact assessment documents
• Monitor pharmacovigilance legislation updates received from LPPVs and other relevant sources • Distribute applicable legislation updates to relevant functional teams in a timely manner

• A Pharmacy degree or life science background).
• Excellent written and oral communication skills in English and Turkish (MANDATORY).
• 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

• Professional growth and career opportunities
• International team and environment
• Health & Life Insurance
• Monthly Food Allowance
• Monthly Transportation Fee
• Remote Work