Junior PV Officer/PV Officer
Location: Remote (Employees can work remotely)
Full-time
Department: ICSR Management
Company: PrimeVigilance (Part of Ergomed Group)
Company Overview:
PrimeVigilance is a specialized, mid-sized pharmacovigilance service provider, established in 2008 and part of the Ergomed Group. With global teams across Europe, North America, and Asia, we provide services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We serve pharmaceutical and biotechnology partners, covering a broad range of therapy areas, including medical devices.
We value our employees and invest in their growth by offering excellent training and development platforms, fostering a healthy work-life balance, and prioritizing well-being and mental health.
Job Overview:
We are looking for a Junior PV Officer/PV Officer to join our team and manage case processing services within pharmacovigilance. As a PV Officer, you will work independently on various case processing activities and take full responsibility for the processes related to Individual Case Safety Reports (ICSRs).
Key Responsibilities:
Case Processing: Handle Individual Case Safety Reports (ICSRs) from all sources (post-marketing and clinical trials, including medical devices and combination products). Ensure compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements.
SAE/SUSAR Management: Independently manage Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) submissions, unblinding, and clinical trial reconciliations.
Periodic Reporting: Prepare database outputs for periodic reporting (e.g., PBRER, DSUR, PADER).
Training and Mentoring: Mentor and train junior employees within the department, optimize procedures, and contribute to process development.
Qualifications:
Educational Background: Life sciences or biomedical degree (e.g., Chemistry, Biology, Biotechnology, Veterinary Science).
Experience: Demonstrated experience in pharmacovigilance case processing.
Skills:
Strong time management, organizational, and multitasking abilities.
Excellent attention to detail.
Strong interpersonal and communication skills.
Advanced English skills (C1 level, both written and verbal).
Why Join PrimeVigilance?
At PrimeVigilance, we prioritize diversity, equity, and inclusion. We create an equal opportunities workplace that values cultural backgrounds, genders, and ages. We believe in the human-first approach, recognizing our employees as our greatest strength.
We offer:
Training and Career Development: Internal opportunities for personal and professional growth.
Global Collaboration: Work with colleagues worldwide, using English as the company language.
Core Values: We operate with values such as Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.
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