Ergomed
pharmacovigilance
SeniorPVAssociate/JuniorPVOfficer
“Senior PV Associate / Junior PV Officer at Ergomed. Skills: Pharmacovigilance case processing, SAE/SUSAR Management, periodic reporting. 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 reconcilia”
What You'll Achieve.
reach and maintain a high level of performance within 3 months of being assigned to an ICSR team
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 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., Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations), Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.), Time and issue management, delegation, organization and multitasking skills with 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.
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; work with colleagues based all over the world; Collaborative Partnerships
Communication Scope
interpersonal and communication skills; Advanced English skills, both verbal and written, at least C1
Process & Methodology
Time and issue management, delegation, organization, multitasking skills
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