HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com
The Pharmacovigilance Director (PV Director) will play a key role in the evaluation of post-marketing adverse events, safety review of post-marketing adverse event reports, and assist with aggregate reports and support signal detection activities for post marketed and pre-marketed programs. The PV Director contributes to the operational activities of the Global safety & Pharmacovigilance functions and ensures that performed tasks comply with the standard operating procedures, best industry standards, and applicable regulations.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and its global office sites is essential.
Primary Duties and Responsibilities
- Maintenance of Pharmacovigilance System Master File.
- Perform safety/medical review of individual case safety review of adverse events post marketing reports,
- Review the SAEs reports and perform analysis of similar events from global clinical trials in accordance with the safety management plans and standard operating procedures.
- Assists with the Aggregate Report (i.e., DSUR and PBRERs) preparation in accordance with appropriate regulations/guidelines and standard operating procedures.
- Assists in signal detection activities, risk management plans, working closely with Clinical and Biometrics teams.
- Perform a literature review for safety data relevant to products.
- Work closely with Vendors and PV Manager in maintaining the global safety database.
- Assist in representing Company during regulatory audits and inspections.
- Support ad hoc safety queries from Regulatory Authorities.
- Assist with response to safety queries from regional safety teams, regional market reportability and medical information
- Assist with development of Standard Operating Procedures.
Job Qualifications and Requirements
- Good working knowledge of drug safety databases (preferably ARGUS) and MedDRA.
- Knowledge of FDA and EU, ICH adverse event reporting regulations, and the ability to apply applicable regulations to maintain compliance.
- Knowledge of safety databases and common software applications; Knowledge of MedDRA terminology, logics/structure, Standardized Queries; Knowledge of US CFR, EMA and ICH Guidelines on pre- and post-marketing surveillance and medical device reporting
- Knowledge of principles of epidemiology and statistics.
- Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.
Education and Experience
- Health care professional degree required (DO, RN, BSN, PA, NP, PharmD)
- Minimum 5-8 years for experience in pharmaceutical drug safety
- Minimum of 10 years’ experience in pharmacovigilance, clinical research or clinical development
- 1-year clinical experience with patients following post-graduate training with significant knowledge of general medicine.
The position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters.