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Case Processing Specialist
hace 2 meses
At PrimeVigilance, we are seeking a skilled Pharmacovigilance Officer to join our team. As a key member of our case processing team, you will be responsible for managing a variety of case processing services with full accountability.
We are looking for a proactive, capable, and motivated individual who aims to surpass any target set in front of them. The ideal candidate will have a life science/bio medical background or another healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.) and have demonstrated experience in case processing.
The Pharmacovigilance Officer will work as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. This role requires a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion.
Responsibilities- Case Processing: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures, and in accordance with client-specific requirements and timelines.
- SAE/SUSAR Management: Independent management of SAE/SUSAR submissions, unblinding, clinical trial reconciliations.
- Database Management: Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
- Mentoring and Training: Mentoring and training of new and more junior employees within the department, including procedure optimization and development.
- Life Science Background: Life science/bio medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
- Case Processing Experience: Demonstrated case processing experience; ARGUS experience preferred.
- Time and Issue Management: Time and issue management, delegation, organization, and multitasking skills with good attention to detail.
- Interpersonal and Communication Skills: Strong interpersonal and communication skills.
- Language Skills: Advanced English skills, both verbal and written, at least C1.
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow. To succeed, we must work together with a human-first approach.
We offer:
- Training and Career Development: Training and career development opportunities internally.
- Personal and Professional Growth: Strong emphasis on personal and professional growth.
- Friendly Working Environment: Friendly, supportive working environment.
- Global Collaboration: Opportunity to work with colleagues based all over the world, with English as the company language.
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
