Pharmacovigilance Director

Location
San Diego, CA
Posted
Jul 08, 2021
Hotbed
Biotech Beach
Required Education
Other
Position Type
Full time

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

Job Summary

 

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.