Apolis · 1 day ago
USA - Project Manager Pharmacovigilance
United States
Full-time
Remote
Senior Level, Lead/Staff
$140/hr - $190/hr
10+ years expApolis is a company specializing in pharmaceutical and biological products, and they are seeking a Project Manager for Pharmacovigilance. The role involves supporting safety surveillance, signal detection, and risk management for oncology products, as well as coordinating communication of safety information across teams.
ConsultingEnterprise ApplicationsEnterprise Resource Planning (ERP)Information TechnologyIT InfrastructureIT ManagementMobileSoftwareWeb Hosting
Responsibilities
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
Represent PSPV in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires
Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the Takeda Safety Board. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, manage the short timelines that can ensue
Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues
Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents
Demonstrate outstanding knowledge of local and global health authority requirements
Support PSPV in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations
Train and mentor newly hired peers and incumbent PV Scientists
Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning
Qualification
Required
Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred
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 preferred
Company
Apolis
Apolis is a IT consultancy that offers provides ERP solutions, hosting, assessment, web and mobile, IT staffing and IT workforce solutions.
501-1000 employees
H1B Sponsorship
Apolis 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
2023 (15)
2022 (15)
2021 (12)
2020 (122)
Funding
Current Stage
Late StageLeadership Team
Amar Shokeen
President/ CEO
Rita Shokeen
COO
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