Description
We are seeking a Pharmacovigilance Scientist to 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.
Responsibilities:
- Evaluate events of special interests as well as aggregate data review
- Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs
- Author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required
- 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 signal evaluation analyses for proactive and timely identification of signals and characterization of risks
- Ensure full documentation and tracking of signals
- Liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders
- Distribute molecule work within team consisting of molecule scientists, when necessary, coordinating support across molecules and disease areas when there are peaks and troughs in workload
- Oversee end-to-end molecule work and ensure consistent tracking of signals from detection to assessment to inclusion in aggregate reports
- Ensure an in-depth knowledge of the molecule and disease area within the service provider molecule team
- Oversee and be responsible for the quality of molecule deliverables to the customer’s molecule team
- Participate in internal and external audits and inspections, as required
- Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required
- Conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members
Qualifications:
- Life science graduate/post-graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- 4-6 years of relevant experience in Pharmacovigilance including hands-on experience of drug safety, aggregate reports, signal detection/signal management preferred
- Excellent communication (written and verbal) skills
- Team working
- English – fluent (spoken, written)