Ergomed

pharmacovigilance

SeniorPVAssociate/JuniorPVOfficer

Bucharest, Bucharest, Romania FULL TIME Remote Friendly
The Brief

“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.

pharmacovigilance

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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