Pharmacovigilance Specialist

About the Role

Delta PV, a prominent pharmacovigilance service provider based in Istanbul, Türkiye and now part of the Biomapas group since August 1, 2025, is seeking qualified Pharmacovigilance Specialists. These specialists will be engaged in providing global operational support for a leading international pharmaceutical company, working on project-specific assignments. Reporting to the Pharmacovigilance Manager of the international company, the role involves responsibilities related to audit and CAPA (Corrective and Preventive Actions) management. The quality oversight team retains the ultimate accountability for quality assessments, CAPA approvals, effectiveness reviews, and closures.

Key Duties

• Maintain and rigorously update the GTEM-7 audit tracking file with precise, up-to-date data.
• Document audit observations, CAPA specifics, owners, deadlines, statuses, and associated details within the Internal file Excel tracker.
• Input approved audit observations and CAPA activities into the Global QMS, ensuring precise recordkeeping and prompt workflow initiation.
• Initiate and administrate approved CAPAs in the Global QMS, overseeing progress, due dates, assignments, and follow-ups.
• Communicate with CAPA owners to collect necessary evidence and confirmed deliverables within deadlines.
• Gather and compile supporting evidence packages from CAPA owners for Quality Oversight team review.
• Continuously monitor unresolved CAPAs and audit findings, proactively addressing overdue items and pending documentation.
• Conduct administrative completeness evaluations of received deliverables before submission for final quality review.
• Maintain trackers for overdue actions, pending evidence, and upcoming deadlines to facilitate monitoring activities.
• Co-ordinate with CAPA owners, including vendors, partners, affiliates, and subject matter experts, to obtain required deliverables tied to audit commitments and CAPA execution.
• Assist with the preparation, assembly, and maintenance of PSMF Annex G1 and Module 7 documentation.
• Issue audit notifications to vendors, partners, and affiliates after audit schedule approval; liaise with functional heads regarding audit reports and notify auditees about CAPA plans.
• Distribute pharmacovigilance questionnaires and manage tracking of responses.
• Compile periodic progress reports on ongoing CAPA plans and status of open observations.

Candidate Profile

• Degree in Pharmacy or a related life sciences field is required.
• Fluency in both English and Turkish, with excellent verbal and written communication skills, is mandatory.
• A minimum of one year of experience in pharmacovigilance.
• Prior experience in pharmaceutical companies is considered an advantage.
• Exposure to audit and CAPA management is beneficial.
• Familiarity with healthcare or life sciences industry is preferred.

Benefits & Perks

• Opportunities for professional development and career advancement.
• Work within an international team and diverse environment.
• Health and life insurance coverage included.
• Monthly allowances for food and transportation provided.
• Full remote work flexibility.