Henlius · 1 month ago
Regional Pharmacovigilance Lead, North America
California, United States
Full-time
Onsite
Senior Level
6+ years expHenlius is seeking a Regional Pharmacovigilance Lead to oversee local PV activities and ensure compliance with FDA and Health Canada requirements. The role involves managing the safety profile of medicinal products, acting as a point of contact for regulatory inspections, and maintaining knowledge of current regulations.
BiotechnologyHealth CareMedicalPharmaceutical
Hiring Manager
Jenny Zou
Responsibilities
Acts as Regional PV Lead to fulfill and oversee local PV activities to ensure compliance with FDA and Health Canada requirements with the support from Henlius global PV system
Contributes Henlius global PV system, including its quality system, such as PV-related procedural documents (e.g., SOPs), PV training of personnel, Audit associated documents, PV system deviations and related CAPAs, to ensure fully compliance to FDA and Health Canada requirements
Manages the medicinal products’ safety profile, including any emerging safety concerns
Cooperates with drug safety physicians from headquarter for the medical review of safety reports and or safety relevant document
Acts as a PV point of contact to FDA and Health Canada and as a primary contributor for PV inspections from FDA and Health Canada
Maintains up-to-date knowledge of current FDA and Health Canada PV regulations and collaborates with relevant functions on implementation of changes in regulations
Has awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to the safety or the safe use of the products
Is aware of the content of Risk Management Plans (RMPs) and local appendix and provides input as needed
Has awareness about additional Risk Minimization Measures (RMMs) and Risk Evaluation and Mitigation Strategy (REMS) and manages the local implementation as needed
Is involved in the review and approval of protocols of any Post-Authorization Safety Studies (PASS) conducted in US and Canada
Ensures a full and prompt response to any request from FDA and Health Canada for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product with support Henlius global PV
Provides input into the preparation of regulatory action in US and Canada in response to emerging safety concerns (e.g., urgent safety restrictions, and communication to patients and healthcare professionals)
Reviews any contractual and or PV agreements involving US and Canada territory with relevant parties (vendors, distributors, affiliate etc.) to ensure adequate address of all pharmacovigilance responsibilities
Qualification
Required
6 years of direct PV experience (mandatory requirement)
Demonstrate expert knowledge in US and Canada pharmacovigilance legislation, skilled and knowledgeable in all aspects of pharmacovigilance, PV system and relative function
Familiar with products safety profile management
Strong interpersonal and presentation skills; exhibits professional maturity, confidence, and competence
Computer skills (e.g., Word, Excel, Outlook, SharePoint)
Fluent in English
Excellent organization skills and sense of urgency/working to tight timelines
Ownership of tasks, open mind, flexible, good communication
Preferred
Clinical Medicine background preferred
Drug Safety Physician working experience preferred
Company
Henlius
Henlius is a rapidly growing biopharmaceutical provider that develops, manufactures, and distributes leading oncology treatments.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$346MKey Investors
ShenZhen GTJA Investment Group
2019-09-25IPO
2018-07-20Series Unknown· $156M
2017-12-22Series B· $190M
Leadership Team
Ping Cao
Sr. VP & Chief Business Officer
Recent News
Qatar Tribune
2026-01-20
South China Morning Post
2026-01-19
BioWorld Financial Watch
2026-01-16
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