Ergomed
pharmacovigilance
SeniorPVAssociate/JuniorPVOfficer
“Senior PV Associate / Junior PV Officer at Ergomed. Skills: Pharmacovigilance 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.. cover all steps of a workflow cycle, except Medical Review.”
What You'll Achieve.
reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion
Industry & Context.
What They're Looking For.
Must Have
Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), demonstrated experience in case processing, Demonstrated case processing experience, Time and issue management, delegation, organization, multitasking skills, good attention to detail, interpersonal and communication skills, Advanced English skills, both verbal and written, at least C1
Nice to Have
ARGUS experience preferred
What You'll Do.
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.
cover all steps of a workflow cycle
except Medical Review.
Independent SAE/SUSAR Management (submissions
clinical trial reconciliations)
Preparation of database outputs for periodic reporting (PBRER
Mentoring and training of new and more junior employees within the department
including procedure optimization and development
How You'll Work.
Team & Collaboration
work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams; work with colleagues based all over the world
Communication Scope
interpersonal and communication skills; Advanced English skills, both verbal and written, at least C1
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