Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2)

**Duties/Responsibilities:**

+ 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 and sig...