Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology

Health Care

251-1K (270)

Founded 2001

5 open positions

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Associate Director International PV

1 month, 3 weeks ago

Bulgaria, Croatia, Czech Republic, Poland, Greece, Hungary

Full-time

Lead

Program Manager

Project and Program Management

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Biomapas

Biotechnology

251-1K

Founded 2001

View All Jobs 5

Description

Lead and oversee the international pharmacovigilance office and ensure alignment with QPPV office strategy and governance.
Manage full pharmacovigilance systems and projects, including oversight of the broader PV system.
Drive quality improvements, process harmonization, and operational efficiency across regions.
Support forecasting, budget planning, RFI/RFP responses, and the financial functioning of the QPPV office.
Maintain the Pharmacovigilance System Master File (PSMF) and oversee local annexes and governance documentation.
Supervise core PV deliverables such as PSURs, RMPs, literature monitoring, SOP updates, safety information handling, and signal management.
Oversee contractual partner safety data exchange agreements and inspection/audit readiness and remediation.
Monitor regulatory changes and ensure legal, procedural, and contractual PV compliance across assigned projects.
Manage and develop the regional QPPV team, including goal setting, performance evaluation, promotions, compensation review, and competence development.
Oversee resource planning, staffing needs, and recruitment, and support project or deputy project manager duties when needed.

Requirements

Degree in biology, pharmacy, medicine, or another life science field.
At least 6 years of experience in pharmacovigilance functions.
At least 1 year of experience managing PV teams.
Team management experience.
Excellent knowledge of international pharmacovigilance regulations, including ICH, EU GVP Modules, UK guidelines, and FDA requirements.
Experience in PV medical writing and project management.
Demonstrated ability to evaluate, interpret, and present safety data accurately and effectively.
Demonstrated ability to implement PV strategies and develop PV systems and procedures.
Professional-level English communication skills, both written and spoken.
Strong leadership, collaboration, decision-making, problem-solving, and communication skills.

Benefits

Professional growth and career opportunities.
International team and work environment.
Annual performance-based bonus.
Personal accident and business trip insurance.
Additional health insurance.
Remote/home-based position.
Rewarding referral policy.
Workplace establishment allowance.

Interested in this position?

Apply directly on the company website

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