Global Safety Associate Medical Director

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 Products   serves 2 roles: 1) safety expert of the assigned   marketed   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   marketed   products.     

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 Safety   Scientists .  

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.g   Core safety information portions of Core Data Sheet [CDS])  

Identify   relevant 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 detection   activities   for 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 ,   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  

M ay search and 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 new or updated risk management plan (RMP) document  

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

Develop materials for   additional   risk minimization measures as applicable to role  

Periodic (aggregate) safety reporting :  

Ensure   timely   preparation 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 :  

Represents   and 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 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  

P artnerships 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 and   participate   in 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  

Assist   in the recruitment of talented GPS and AMGEN staff  

A ccountable for   disseminating   and   representing   corporate 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 product   labelling  

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  

O ther 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)  

C ompetencies  

KNOWLEDGE :  

Serves as a technical authority within the organization  

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

P ROBLEM SOLVING :  

Applies global thought leadership  

Shapes long-term strategic direction and reputation of Amgen  

Provides   authoritative advice to top management  

Leads organizational invention at a global level  

AUTONOMY :  

Models   organizational 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 equivalent   degree 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)  

MBBS   or equivalent degree from an accredited medical school  

12 years of   directly related   experience OR MD of a foreign medical school  

AND  

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

Previous   management and/or mentoring experience  

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

.