Clinical & Coding Specialist - Senior responsible for reviewing coding and clinical decisions for complex cases. Supporting team training and audit processes at Independent Health in Buffalo, NY.
CS
Hybrid Lead Post Marketing, Medical Coding, Device Safety PV Scientist
Posted 2 months ago
About the role
- Lead PV Scientists for lifecycle safety and risk management activities at CSL. Drive innovation in dynamic biotech ecosystems while ensuring safety management for products with existing marketing authorizations.
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.
Requirements
- 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
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
- You Belong at CSL
- At CSL, Inclusion and Belonging is at the core of our mission and who we are.
- Equal Opportunity Employer
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