Informacje o stanowisku

At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. We are always looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them.

The PV Officer should be a Life science / bio medical background graduate or have other healthcare-related degree qualifications (chemistry, biology, biotechnology, veterinary science, etc.) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Responsibilities

Responsibilities include:

1. 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. As a key member, there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
2. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
3. Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
4. Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

Qualifications

Life science / bio medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.

Demonstrated case processing experience.

Time and issue management, delegation, organization, and multitasking skills with good attention to detail.

Strong interpersonal and communication skills.

Advanced English skills, both verbal and written, at least C1.

Additional Information

Why PrimeVigilance?

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. Why? Because our people are our greatest strength leading to our continued success in improving the lives of those around us.

We offer:

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you, then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging

We look forward to welcoming your application.

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