Amgen Global Safety Officer (Biosimilars Lead) in Thousand Oaks, California

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).

  • Applicable tasks may vary by Biosimilar product(s) assigned

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

  • Accountable for timely preparation and quality of TA Safety contributions to periodic reports (e.g., PSUR/PBRER, DSUR)

  • Review and approve periodic safety reports

Safety Governance Leadership

  • Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents)

Vendor Oversight

  • Business lead for vendor relationship; attend all joint management meetings

  • Management of Vendor/business partner relationship and successful issue management

  • Oversee day-to-day issues; final decision on escalated issues

Inspection Readiness

  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Other Amgen processes

  • Interact with external stakeholders (e.g., advisory boards) on safety-related topics

  • Prepare for and participate in regulatory agency advisory committees

  • Provide safety input to support legal needs

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

Other skills

  • Strategic thinking

  • Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment

  • People and team management

  • Conflict management

  • Organization, prioritization, and planning of work

  • Project management

  • Oral presentation skills

  • Written communications and medical/scientific writing

  • Computer skills (e.g., MS Office Suite and safety systems)

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

Preferred Qualifications

  • MD and 3+ years of directly related PV experience

  • Product safety in the bio/pharmaceutical industry or regulatory agency

  • Previous management and/or mentoring experience

MD01

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Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.