Radiant Systems Inc · 1 day ago
Associate Director, Pharmacovigilance
United States
Contract
Remote
Lead/Staff, Director/Executive
$80/hr - $150/hr
10+ years expRadiant Systems Inc is seeking an Associate Director in Pharmacovigilance for their Global Medical Safety Oncology team. The role involves supporting safety surveillance, signal detection, and risk management activities for oncology pharmaceutical products, while providing expertise and coordination for safety data analysis and communication of safety information.
CRMInformation TechnologySoftware
Responsibilities
Supports the Global Safety Lead (GSL) for assigned oncology pharmaceutical / biological / drug-device combined products
Responsible for safety surveillance, signal detection and risk management activities
Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products
Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products
Represent pharmacovigilance, both regionally and globally, as an authoritative and knowledgeable member of Global Program Teams (GPTs) and subteams, commensurate with position’s seniority/experience
Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with the GSL, for assigned product(s)
Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature
Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT)
Coordinate and perform signal identification, evaluation and management activities for assigned products, ensuring communication of all safety information that may impact the benefit-risk profile of assigned products to senior management
Assist with or lead authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses
Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs
Liaise with colleagues in relevant functional areas within and outside of PSPV to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs)
Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focussed safety data
Support PSPV in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations
Qualification
Required
Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification
Minimum 10 years of relevant biotech/pharmaceutical experience
Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches
In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development
Preferred
Advanced degree in scientific or medical field
Company
Radiant Systems Inc
Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
501-1000 employees
H1B Sponsorship
Radiant Systems Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Late StageLeadership Team
Rayn Kamesh
Head of Sales/Director, Strategic Partnership - MSP/VMS Accounts
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