The Global Safety Officer (GSO)for Marketed Productsserves 2 roles: 1) safety expert of the assignedmarketedproduct(s),establishingthe strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assignedmarketedproducts.  

The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global SafetyScientists

Key Activities

Applicable tasks may vary by product(s) assigned.

Product safety profile, benefit-risk evaluation, and risk communication

• Accountable for the Development and maintenance of core reference safety information (e.gCore safety information portions of Core Data Sheet [CDS])

• Identifyrelevant data and conduct benefit-risk evaluation

• Participate in product label process

Clinical trial safety

• Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing.

• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees

• Perform signal detectionactivitiesfor developmental products under the direction of the GSO leading the product in development.

Signal detection, evaluation, and management

• Develop signal detection strategy

• Evaluate safety signal detection findings,validatesignalsanddeterminea need and develop a strategy forfurther analysis

• Decide on need for further actions on safety issues and lead cross-functional discussion

• Documents work asrequiredin the safety information management system

• Prepares and presents recommendations on safety issues to the Global Safety Team and escalates asappropriate tothe executive level cross-functional decision-making body

• Approves the safety assessment report

• May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection

• Documents work asrequiredin the safety information management system

Risk management and minimization

• Ensuretimelypreparation, content, and quality of new or updated risk management plan (RMP) document

• Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)

• Develop materials foradditionalrisk minimization measures as applicable to role

Periodic (aggregate) safety reporting

• Ensuretimelypreparation and quality of periodic reports (e.g., PSUR/PBRER)

• 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)

Amgen commercialization process

• Representsand contributes on behalf of Global Patient Safety on Evidence Generation Teams

Inspection Readiness

• Undertake activities delegated by the QPPV as detailed in the PV System Master File andmaintaina 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

• Partnerships and integration activities

• Participate in safety agreement development and review process

• Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

• Perform safety due diligence in preparation for partnerships, etc

• Participate in integration activities

Other Amgen processes

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

• Prepare for andparticipatein regulatory agency advisory committees

• Provide safety input to support legal needs

• Managerial and supervisory responsibilities

• Oversees day to day activities of the Global Safety Physician if applicable

• Ensure staff are compliant with Amgen corporate and departmental training and SOP review

• Provide training, coaching, mentoring, and development of staff

• Assistin the recruitment of talented GPS and AMGEN staff

• Accountable fordisseminatingandrepresentingcorporate and departmental information to staff and ensuring understanding and adherence to changes

• Development plans for staff created annually and reviewed quarterly

Knowledge and Skills

• 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 productlabelling

• 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 toanalyzeand 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

• Big picture perspective and context analysis

• People and team management

• Conflict management

• Organization, prioritization, and planning of work

• Project management

• Critical scientific assessment and problem solving

• Oral presentation skills

• Written communications and medical/scientific writing

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

Competencies

KNOWLEDGE

• Serves as a technical authority within the organization

• Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability

PROBLEM SOLVING

• Applies global thought leadership

• Shapes long-term strategic direction and reputation of Amgen

• Providesauthoritative advice to top management

• Leads organizational invention at a global level

AUTONOMY

• Modelsorganizational standards for innovation

• Directs projects of critical importance to Amgen

CONTRIBUTION

• Serves as expert advisor to top management and is a sponsor for large-scale projects

• Ensures products and services are aligned with current and future needs and expectations including the following:

• Business needs

• Medical field

• Research community

• Creates solutions that enhance Amgen’s intellectual property

Education & Experience (Basic)

MBBS or equivalentdegree from an accredited medical school

AND

Completion of an accredited medical or surgical residency

OR

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting 

Education & Experience (Preferred)

MBBSor equivalent degree from an accredited medical school

12 years ofdirectly relatedexperience OR MD of a foreign medical school

AND

Product safety in the bio/pharmaceutical industryCROor regulatory agency

Previousmanagement and/or mentoring experience

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting