Global Safety Officer (Biosimilars Lead)

Employer
Amgen
Location
Thousand Oaks, California
Posted
Oct 23, 2018
Ref
R-65107
Required Education
Bachelors Degree
Position Type
Full time

The Global Safety Officer (GSO) remit includes:

  • Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned post approval products.
  • GSO leads the Safety Analysis Team (SAT), the US Risk Minimization Implementation team (US RMIT) and the EU RMIT teams and the cross-functional Global Safety Team (GST).
  • The GSO is a core member of the Executive Safety Committee. The GSO can be assigned as delegate for the TAH as needed.
  • The GSO also works with Functional Service Provider staff to ensure high quality of the safety deliverables provided in support of Amgen pharmacovigilance including signal detection, signal management, periodic aggregate safety reports and benefit-risk assessment of products.
  • Serves as point of contact for cross functional Amgen staff supporting biosimilar products (e.g. regulatory, clinical, quality, etc).

Signal detection, evaluation, and management

  • Develop signal detection strategy for Biosimilars at approval of Biosimilar
  • Evaluate safety signal detection findings validate signals and determine a need and develop a strategy for further analysis
  • Decide on need for further actions on safety issues and lead cross-functional discussion
  • Documents work as required in the safety information management system
  • Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body
  • Approves the safety assessment report
  • May review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • Documents work as required in the safety information management system

Risk management and minimization

  • Ensure timely preparation, content, and quality of updated EU Risk Management Plan (RMP) document
  • Lead the development of a strategy for implementing and evaluating (if applicable) safety risk minimization measures globally (including US REMS if applicable)
  • Develop materials for additional risk minimization measures as applicable to role
  • Monitor implementation of additional risk minimization activities globally.
  • Initiate evaluation of the effectiveness of additional risk minimization measures in EU if applicable.
  • Supports Local Safety Officers (LSOs) in development of their local RMP and additional risk minimization measures.

Periodic (aggregate) safety reporting

Safety Governance Leadership

Vendor Oversight

Inspection Readiness

Processes and regulations for pharmacovigilance and risk management

  • Advanced understanding of interfaces across various pharmacovigilance and risk management processes
  • Drug development and lifecycle management
  • Safety data capture in clinical development and post-market settings
  • Safety database structure and conventions
  • MedDRA and other dictionaries used in pharmacovigilance
  • Methods of qualitative and quantitative safety data analysis
  • Product and disease state knowledge
  • General medicine, epidemiology, physiology, and pharmacology
  • Internal organizational and governance structure
  • Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

Pharmacovigilance skills

  • Signal detection and evaluation
  • Aggregate data analysis
  • Good clinical and scientific judgment
  • Application of medical concepts and terminology
  • Document writing and source document review
  • Data interpretation and synthesis
  • Basic skills in application of statistical and epidemiological methods to pharmacovigilance
  • Ability to convey complex, scientific data in an understandable way
  • Ability to analyze and interpret complex safety data
  • Advanced skills in application of statistical and epidemiological methods to pharmacovigilance

Basic Qualifications

MD or DO degree from an accredited medical school
AND
Two (2) years of clinical research experience and/or basic science research
OR
Significant interest in Biosimilars