SPECTRAFORCE · 22 hours ago
Pharmacovigilance Associate Director (Oncology)
United States
Contract
Remote
Lead/Staff, Director/Executive
$80/hr - $100/hr
10+ years expSPECTRAFORCE is seeking an Associate Director, PV Sciences – Global Medical Safety (Oncology) to support global pharmacovigilance activities for oncology products. This role involves leading safety surveillance, signal detection, risk management, and ensuring regulatory compliance throughout the product lifecycle.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Neeraj Singh Rajput
Responsibilities
Support the Global Safety Lead (GSL) for assigned oncology pharmaceutical, biological, and drug–device combination products
Lead and/or support safety surveillance, signal detection, and risk management activities
Support cross-functional assessment of benefit–risk profiles and communication of safety information for assigned products
Provide pharmacovigilance expertise to global project teams for developmental and marketed products
Represent Pharmacovigilance as a senior, authoritative member of Global Program Teams (GPTs) and subteams
Coordinate signal detection, safety surveillance, and review activities in collaboration with the GSL
Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature sources
Facilitate ongoing safety surveillance and contribute to data collection and assessment for Safety Teams (GST/SMT)
Coordinate and perform signal identification, evaluation, and management, ensuring timely communication of safety issues impacting benefit–risk profiles
Assist with or lead authoring of aggregate safety reports, safety evaluations, Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses
Partner with cross-functional colleagues to support regulatory submissions, benefit–risk assessments, and risk minimization activities (e.g., RMPs)
Liaise with internal and external functional areas to support safety sections of key documents, including protocols, IBs, CSRs, INDs, NDAs, BLAs, CTAs, and core data sheets
Represent Global PV in cross-functional teams, committees, and external forums at global and regional levels
Assist with or lead preparation and presentation of safety risks and recommendations to senior decision-making bodies (e.g., Safety Boards)
Maintain in-depth knowledge of assigned products, studies, and protocols to effectively respond to safety issues
Ensure safety information is current and accurate in Company Core Data Sheets, Reference Safety Information, Investigator Brochures, and labeling documents
Demonstrate strong knowledge of global and local health authority requirements
Support maintenance of a compliant and effective global pharmacovigilance organization
Train and mentor PV Scientists and support continuous learning within the function
Qualification
Required
Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent; advanced scientific or medical degree preferred
Minimum 10 years of relevant experience within biotech or pharmaceutical environments
Strong understanding of pharmacovigilance regulations, safety surveillance, signal detection, and benefit–risk assessment
Excellent working knowledge of safety databases, adverse event coding, and advanced data searches
In-depth understanding of clinical trial methodology, drug development, and safety data analysis
Strong communication, leadership, and cross-functional collaboration skills
Ability to operate independently in a global, fast-paced environment
Preferred
advanced scientific or medical degree
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE 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
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Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase