Act as signal detection and literature lead, or back-up lead to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products, evaluating events of special interests as well as aggregate data review
Author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs and ACOs.
Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Can serve as principal owner (molecule lead) for the molecule and have responsibility for completion of the deliverable and in compliance with all applicable Key performance indicators (KPI); Set-up and update products' signaling strategies, as approved by the customer’s Safety Strategy Lead. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation a...