PV Officer

Ergomed • Raleigh, NC

1d

About The Position

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 trial, 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 qualification (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. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion.

Requirements

• 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

Nice To Haves

• ARGUS experience preferred

Responsibilities

• 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.
• Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
• Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
• Mentoring and training of new and more junior employees within the department, including procedure optimization and development

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees