Pharmacovigilance 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

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