Pharmacovigilance Associate-
Manages adverse events: processes adverse-event case reports and conducts follow-up;
notifies regulatory agencies and business partners accordingly;
responds to requests from regulatory agencies;
reviews scientific literature and bibliographic sources;
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helps draft and manage periodic safety-update reports;
evaluates safety profiles; ensures document filing and archiving. Involved in clinical-trial activities: reviews the pharmacovigilance aspects of protocols and other documents;
ensures management of adverse-event case reports;
reconciles information in pharmacovigilance and clinicalresearch databases.
Contributes to ensure compliance of pharmacovigilance activities: assures compliance of pharmacovigilance activities;
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conducts case reconciliation with concerned departments or business partners;
takes part in audits and inspections. Serves in an advisory capacity: revises product monographs;
drafts responses to pharmacovigilance requests from regulatory agencies;
advises and informs health professionals about product safety; participates in the drafting and implementation of pharmacovigilance contracts and agreements.
Interested to apply can share CV to info@quisconbiotech.com or call/whatsapp to 8015344631
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