Job Title: Senior Pharmacovigilance Physician I
Location: Zagreb, Croatia
Job Type: Full-time
Department: PV Medical Group
About the Company:
PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. With consistent global organic growth, PrimeVigilance supports pharmaceutical and biotechnology partners across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company covers all therapy areas, including medical devices, and fosters long-lasting relationships with clients. PrimeVigilance is committed to investing in employee well-being and providing excellent training and development opportunities while emphasizing work-life balance.
Job Responsibilities:
Medical/Causality Assessment:
Review and approve post-marketing ICSRs and SAE reports occurring in clinical trials, including coding, seriousness assessment, causality, listedness/expectedness, and follow-up questions
Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in evaluating safety issues
Periodic Reports & Literature Review:
Provide input and review Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening search strategy
Review articles to identify ICSRs/SAEs and other safety-related findings
Risk Management:
Assist in preparing and reviewing Risk Management Plans and providing input for responses to regulatory authority requests
Signal Detection:
Participate in signal detection activities, including meetings and report writing
Evaluate and categorize potential signals, proposing appropriate courses of action
Support preparation and review of benefit-risk reports
Required Qualifications:
Education:
Medically qualified as a physician
Experience:
Previous experience in pharmacovigilance
Expertise in signal detection activities
Ability to review aggregate reports such as PBRERs and DSURs
Skills:
Strong interpersonal and communication skills
Excellent planning, organization, and multitasking abilities
Cross-functional and cross-cultural teamwork skills
Advanced proficiency in English (spoken and written)
Advanced MS Office skills
Additional Information:
PrimeVigilance values diversity, equity, and inclusion, fostering an environment where people from all cultural backgrounds, genders, and ages can contribute and grow.
The company embraces a human-first approach, recognizing that its people are the greatest strength in driving success and improving lives globally.
PrimeVigilance offers internal training, career development, and a friendly working environment with global colleagues.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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