At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.
Responsibilities :
Processing of individual case safety reports from all sources (clinical trials, post-marketing, device, and combination goods) in conformity with PrimeVigilance protocols, applicable laws, and client-specific deadlines and specifications.
It is expected of you as a key member to efficiently handle every stage of the workflow cycle—with the exception of medical review.
Independent SAE/SUSAR Management (reconciliations of clinical trials, unblinding, and submissions)
Preparing database outputs (PBRER, DSUR, PADER, etc.)
For periodic reporting mentoring and training of new hires and less experienced staff members in the department, including duties related to Qcing and process development and optimization
Requirements :
Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
Must have previous QC experience
Demonstrated full start to finish case processing experience
ARGUS/Aris G experience preferred
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
Dr. Elliot Brown and Dr. Miroslav Reljanovic joined forces to form PrimeVigilance, an Ergomed Group firm, in 2008. To support pharmaceutical, biotechnology, and medical device industries, PrimeVigilance provides comprehensive, superior, economical, and creative clinical safety and PV services. We have a global network of SMEs under our leadership, and they enjoy an unparalleled reputation in the industry. Some of these have extensive industry experience and include former senior regulators and consultants.
By fusing regulatory science with medical and scientific knowledge in clinical settings and daily practice, we complement our domain experience. To maximize the safe and efficient use of medications and medical technologies, we find hitherto undiscovered adverse effects or alterations in their patterns. Together with our flexibility as a partner, our flexible business models and integrated project management constantly meet our clients' business needs and protect their assets.Our team of 1000 professionals spans three continents and is unmatched in clinical safety and pharmacovigilance due to its talents, values, and inventiveness. We put our customers in touch with the appropriate safety resources and solutions.