Description
As a stand-alone global functional lead at a project level, you will apply your experience, knowledge, and expertise to Safety Aggregate Report and Analytics (SARA) Center deliverables, including safety aggregate reports, literature surveillance, signal management activities, and benefit-risk management documents.
You will actively contribute to Lifecycle Safety global process initiatives and work closely with the safety customer delivery management team regarding project/client initiatives.
Key responsibilities:
- Serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects
- Lead, author, and finalize aggregate reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries
- Conduct ongoing literature safety surveillance for marketed and investigational products
- Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects
- Oversee/conduct ongoing signal detection activities, perform signal validation, and signal evaluation analyses
- Provide training to SARA staff for qualification on SARA deliverables
- Perform quality checks of all assigned SARA deliverables
- Provide consultative guidance to internal and external stakeholders for all SARA deliverables
- Act as mentor to and coach project team staff and direct line reports
- Interface with clients and other functional groups within Lifecycle Safety and other business units
- Participate in internal and external audits, as required
- Lead functional team and contribute to achievement of departmental goals
- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required
Requirements:
- Life science graduate/post-graduate, pharmacy, nursing, or other healthcare-related qualification or experience in pharmacovigilance
- 5-10 years of relevant experience in Pharmacovigilance, including hands-on experience of drug safety, aggregate reports, signal detection/signal management
- Excellent communication (written and verbal) skills
- Strong organizational and time management skills, with the ability to meet strict deadlines
- Manage competing priorities and ability to be flexible and receptive to changing demands
- English – fluent (spoken, written)