Puma Biotechnology, Inc. · 19 hours ago
Manager, Pharmacovigilance - Remote Position
United States
Full-time
Remote
Mid Level
$120K/yr - $145K/yr
3+ years expPuma Biotechnology Inc. is a company focused on drug development and safety. They are seeking a Manager of Pharmacovigilance to provide proactive safety surveillance across the lifecycle of Puma products and support the development and execution of Risk Management Plans.
BiotechnologyMedicalTherapeutics
Responsibilities
Perform periodic aggregate safety data review according to a signal detection strategy and escalate possible safety issues to AD Pharmacovigilance and Clinical/Medical Monitor as needed for assigned product(s)
Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for safety signal detection
Collaborate with PV lead in the preparation DSURs, PSURs, PADERs, PBRERs as appropriate
Monitor medical and scientific literature for published articles relevant to the safety profile for assigned product(s)
Plan and perform analysis in support of response to regulatory agencies, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
Support development and execution of risk management plans, risk assessment, and risk communications
Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, Informed Consent, Company Core Data Sheets, product labels, etc
Provide support for developing and updating Investigator Brochures and study protocols
Provide and present safety data analysis in support of Safety Review Committee (SRC)
Collaborate with data management as needed, and review data in Clinical database as part of signal management process ensuring appropriate safety reporting
Lead efforts to improve processes and increase work efficiency applicable to Pharmacovigilance
Remain in compliance with active Puma standard processes and procedures
Execute triage for appropriate causality assessment on Individual Case Safety Report (ICSRs) for regulatory reporting
Perform medical review of ICSR, query sites for additional information and collaborate with Clinical Operations as needed
Write narratives, review of SAE for clinical content, accuracy and completeness
Create follow-up queries, and case follow-up measures for case processing
Manage and ensure compliant safety reporting in accordance with local and international reporting regulations, and/or standard operating procedures
Qualification
Required
BS/BA degree in a health related (e.g., RN/BSN, RPh) or biological science field (e.g., B.S. in Biology), or advance degree (e.g., MD, PharmD, PhD, PA) and, minimum 3 years of biotech/pharmaceutical experience in Drug Safety/Pharmacovigilance
Minimum 3 years in Pharmacovigilance & Risk Management
Strong working knowledge of US/EU/AP/LA regulations, ICH, and GVP guidelines
Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
Experience in phase I-IV drug safety surveillance and preparation of investigational and post-marketing regulatory reports
Experience working in electronic document management systems
Must have the ability to work independently in a fast-paced results-driven environment
Ability to make basic decisions (e.g., categorizing serious and non-serious adverse events, routine coding) with an understanding of the result and impact
Proven ability to seek and utilize information and solve complex problems
Excellent interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups
Proficiency in the processing and assessment of safety data (pre and post marketing)
Ability to critically analyze individual and aggregate safety data with scientific rigor
Proven ability to critically evaluate and summarize clinical and scientific data
Ability to create narrative/narrative summaries, safety analysis documents, and/or safety sections of regulatory documents
Demonstrate computer literacy, with proficiency in the used and management of safety databases, strong computer skills such as Word, Power Point, and Excel
Preferred
Experience with MedDRA, WHO, ARGUS safety database and Veeva Safety database will be a plus
Benefits
Annual bonus target
Robust benefits package
Company
Puma Biotechnology, Inc.
At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$809.3MKey Investors
Athyrium Capital Management LPAdage Capital Management
2022-03-10Post Ipo Equity· $10M
2021-07-26Post Ipo Debt· $125M
2017-11-02Post Ipo Equity· $100M
Leadership Team
Maximo Nougues
Chief Financial Officer
Gordon Esplin
Chief Accounting Officer
Recent News
2025-12-24
2025-11-08
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