Team Leader

Daniel Yang, M.D., Ph.D.

 

Doctor Yang has over 30 years of experience in the medical world and has used his educational background to build a wide range of experience both domestically and internationally.

 

As an expert in medical safety and post marketing pharmacovigilance, his past professional experience includes working for large pharmaceutical company (e.g., nearly 10 years with Bristol-Myers Squibb where he served as a medical director and global safety management team leaders in multiple therapeutic areas such as Oncology, Anti-infectives, and Cardiovascular disorders) as well as in large and small CROs where he first fostered hands-on experience in the field.

 

For the past 8 years, Dr. Yang and his medical safety expert team has provided reliable high quality global standard services around the clock, for small, medium and large size pharmaceutical companies in the US and Asian Pacific regions.

 

By partnering with a safety IT Company that helps to provide global standard safety database and safety signal and data management tools, Dr. Yang and his company G2 BioPharma Services Inc. are ready to provide best-in-class pharmacovigilance and risk management solutions for their clients.

 

 

Expertise Highlights


Rich pharmaceutical industry experience with extensive expertise and proven excellence in pre- or post-approval global clinical safety and pharmacovigilance:

 

  • Management of multidisciplinary matrix global medical safety surveillance teams
  • Safety signal detection and data mining (e.g., MGPS)
  • Product risk management plans (e.g., EU RMP, US REMS)
  • Global company or development core safety information or local labels (including CCDS, IB, USPI, SmPC)
  • Medical safety assessment of individual case safety reports (ICSRs) (e.g., SAEs, ESRs, or SUSARs) or periodic aggregate safety updates (e.g., PSUR, PADER, ASR, DSUR, PBRER)
  • Integrated safety summary documents (e.g., SCS, ISS) or other safety related clinical trial documents (e.g., protocols, CSRs, IB, CRF, ICF)
  • Medical safety monitoring for Phase 1-4 clinical trials with good knowledge of GCP and clinical project management
  • Support of global regulatory filings (e.g., NDA, MAA submissions)
  • Knowledge and experience in pharmacoepidemiology and biostatistics
  • Assessment of product quality issues and product recall/withdraw
  • Training new safety physicians or scientists
  • In-depth knowledge and experience in PV system, clinical database, clinical safety and PV outsourcing or off-shore activities

 

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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