Responsibilities include:
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. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
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
Life science / bio medical background - healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
Demonstrated case processing experience
ARGUS 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
Role: Medical Record / Health Informatics
Industry Type: Pharmaceutical & Life Sciences
Department: Healthcare & Life Sciences
Employment Type: Full Time, Permanent
Role Category: Health Informatics
Education
UG: Any Graduate
PG: Any Postgraduate
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Punjab :
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Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
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Jeddah | Najran |