Job Title:
Pharmacovigilance Officer, Team Leader (Line Management Position)
Location:
Sofia, Bulgaria
Employment Type:
Full-time
Department:
ICSR Management
Company Overview:
PrimeVigilance, part of the Ergomed Group, is a specialised mid-size pharmacovigilance service provider established in 2008. With staff across Europe, North America, and Asia, the company delivers services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in its field. The company invests in staff training and development and emphasizes work-life balance to foster high-quality client service.
Job Overview:
The Pharmacovigilance Officer, Team Leader, is responsible for overseeing ICSR management activities, ensuring compliance with applicable regulations and client requirements. The role involves mentoring, line management, and providing PV support to clients and internal teams.
Key Responsibilities:
ICSR & Safety Management:
Process Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations, PrimeVigilance procedures, and client-specific requirements.
Perform ICSR follow-up and SAE/SUSAR management, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.
Conduct clinical and partner reconciliation.
Manage personal data protection and product quality complaints, interacting with Quality Assurance.
Collaborate with Medical Information for safety-related inquiries.
Conduct MedDRA and WHO coding.
Generate database outputs and reports, including monthly client reporting.
Team Leadership & Mentoring:
Mentor and train new and junior staff within the department.
Manage workflow and resources effectively.
Support ICSR Subject Matter Experts (SMEs) and contribute as an ICSR SME.
PV Support & Compliance:
Support PV processes related to ICSR management for PrimeVigilance and clients.
Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated countries/languages.
Assist the RA & PV Network Department as required.
Qualifications:
Life science graduate, pharmacy, nursing, or other healthcare-related qualification, or equivalent PV experience.
Extensive ICSR experience including mentoring and line management.
Excellent communication skills (written and verbal).
Strong organizational skills, attention to detail, multitasking, delegation, planning, and time management.
Technical proficiency and team-working ability.
Fluent in English (spoken and written).
Why PrimeVigilance:
Opportunities for internal training and career development.
Emphasis on personal and professional growth.
Friendly, supportive, international working environment.
Collaboration with colleagues worldwide, using English as the company language.
Core Values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
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