Senior Life & Health Underwriter – Hybrid Africa

Nacba; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Nacba seeks a Pharmacovigilance Scientist 2 to lead signal detection and safety data aggregation across multiple markets. You will manage literature surveillance and author critical safety documents for marketed and investigational products, ensuring timely, compliant outputs.

Responsibilities include creating PBRERs/PSURs/DSURs, replying to regulatory inquiries, and coordinating cross-functional teams to deliver molecule deliverables with high quality and on schedule.

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.

Responsibilities

• Act as signal detection and literature lead, or back-up lead to contribute to surveillance for marketed/investigational products and review aggregate data.
• Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs.
• Author responses to regulatory agency/PRAC inquiries, as required.
• Lead/supervise molecule deliverables, set-up signaling strategies, and author/review signal management deliverables.
• Ensure completion of molecule deliverables on time and coordinate with cross-functional stakeholders.
• Distribute molecule work within the team and coordinate across molecules/disease areas when workload peaks.
• Oversee end-to-end molecule work tracking from detection to inclusion in aggregate reports.
• Maintain in-depth knowledge of the molecule and disease area within the service provider team.
• Ensure quality of molecule deliverables, contribute to DSR conclusions, and participate in SD/Lit meetings.
• Resolve issues on molecule deliverables in collaboration with process leads.
• Participate in internal and external audits and inspections, as required.
• Read, acknowledge and adhere to IQVIA SOPs and customer SOPs; complete required training timely.
• Conduct regular lessons learned with teams to cascade information from the customer.

Skills

Communication skills

Team working

Education

Life science degree

Job description

Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2)

Belgrade, Serbia
Lisbon, Portugal
Bloemfontein, South Africa
Zagreb, Croatia
Athens, Greece
Centurion, South Africa
Sofia, Bulgaria
Evosmos, Greece
New Cairo, Egypt
Bellville, South Africa
Full time
R

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 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.
• Ensuring the completion of molecule deliverables on time and liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders.
• Distribution of 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.
• End-to-end molecule work oversight and responsibility (i.e., ensuring consistent tracking of signals from detection to assessment to inclusion in aggregate reports).
• Ensuring an in-depth knowledge of the molecule and disease area within the service provider molecule team.
• Oversight and responsibility of quality-of molecule deliverables to the customer's molecule team, with "hands-on" involvement, i.e., involved in authoring DSR conclusion, participating in SD/Lit meetings between service provider and customers.
• Responsible for resolution of issues on molecule deliverables (if necessary, in collaboration with 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 as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented
• 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