Amgen
Global Safety Associate Medical Director
India · On-site · Full time
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About the role
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- EmployerAmgen
- LocationIndia
- Work styleOn-site
- Employment typeFull time
- Employer posted
Career Category
Safety
Job Description
The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
Job Summary
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.
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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 industry/CROor regulatory agency
Previousmanagement and/or mentoring experience
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
.
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At a glance
- Work styleOn-site
- Employment typeFull time
- SeniorityEntry level
- Employer posted
- Added to ROLIVA
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