Ergomed
Location
Bangalore | India
Job description
Responsibilities :-
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 expe
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