Pharmacovigilance Scientist 2 (Safety Aggregate Report …, Bloemfontein

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 be 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 or 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, as approved by the customer’s Safety Strategy Lead. Responsible for full documentation and tracking of signals.

Ensure delivery of molecule deliverables on time and liaise with portfolio clinical science scientists, service provider process leads and cross‑functional stakeholders.

Distribute molecule work within a team consisting of molecule scientists, coordinating support across molecules and disease areas when workload peaks.

End‑to‑end molecule work oversight and responsibility (i.e., ensuring consistent tracking of signals from detection to assessment to inclusion in aggregate reports).

Maintain an in‑depth knowledge of the molecule and disease area within the service provider molecule team.

Oversee and ensure the quality of molecule deliverables to the customer’s molecule team, with hands‑on involvement in authoring DSR conclusions and participating in SD/Lit meetings between service provider and customers.

Resolve issues on molecule deliverables as necessary in collaboration with the service provider process lead.

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. Ensure all required training is executed in a timely fashion to maintain compliance and documented evidence.

Qualifications

Life science graduate/post‑graduate, pharmacy, nursing, or other healthcare‑related qualification or experience in pharmacovigilance.

4–6 years of relevant experience in pharmacovigilance, including hands‑on experience with drug safety, aggregate reports, signal detection and signal management preferred.

Excellent written and verbal communication skills.

Team‑work ability.

Fluent English (spoken and written).

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