Process Training Lead & Learning Coach

Anonymous; Cape Town; On-site; ZAR 700,000 - 1,000,000; Full time

Job summary

Anonymous is seeking a Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2) to lead signal detection and literature surveillance across multiple projects, with on-site roles in Centurion, Bloemfontein and Bellville, South Africa, and additional global locations.

The role involves authoring PBRERs/PSURs/DSURs and ACOs, responding to regulatory inquiries, ensuring timely molecule deliverables, and coordinating with cross-functional teams in a fast-paced pharmacovigilance

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/ 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 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
• 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

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