Post Marketing, Medical Coding and Device Safety PV Scientists Lead
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Post Marketing, Medical Coding and Device Safety PV Scientists Lead is the line manager of PV Scientists that primarily serve as key contributors to lifecycle safety and risk management activities for CSL products, specifically for products with existing open marketing authorizations, providing strategic input into the process and ensuring scientific analyses are conducted with rigor, with the goal of proactive safety management. Your responsibilities
Ensure implementation of GVP compliant PV standards, processes by the Pharmacovigilance Scientists, Device expert, and Medical coding expert under their management and conducts cross-functional collaboration with relevant individuals within PV as well as with key stakeholders PVS support for products in the post-marketing phase, as well as those products with ongoing clinical development as required Collaboration with Signal Management/Governance/Literature and Aggregate Reports/Risk Management Heads to support the work of PVS within the team, specifically in the contribution to signal detection and assessment activities through the full governance process, literature screening, and key contributions to aggregate reports, risk management plans, and other PVS-assigned responsibilities Utilization of managed service partners, ensuring on-time delivery of high-quality outputs assigned with implementation of meaningful KPI measures and regular reporting to senior management will be required Creating and implementing a vision which incorporates new technologies and innovative approaches will be essential to lead the team, while ensuring consistent support of the product-responsible GSLs.
Your Experience:
PhD, PharmD, Masters, or equivalent in Medicine, Pharmacy, Epidemiology or related field 8+ years progressive experience in pharma/biotech with at least 3 years direct experience as a Pharmacovigilance Scientist and/or in combination other related PV science function Strong knowledge of ICH, GCP, GVP regulatory requirements as well as clinical development with advanced understanding of Pharmacovigilance, specifically signal detection and management, as well as clinical trial safety Strategic thinking/problem-solving skills with strong communication/interpersonal skills, with the ability to analyze, synthesize, interpret, and present scientific data Ability to manage multiple projects and timelines in a cross-functional environment Experience in working with managed service providers Experience across multiple therapeutic areas is strongly preferred Some international travel will be expected
This role can be base in Melbourne, Australia - Zurich, Switzerland or King of Prussia.
#Jobster