Global Safety Medical Director - Global Safety Officer - Thousand Oaks, CA | Biospace
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Global Safety Medical Director - Global Safety Officer

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
12/6/2016
Position Type:
Full time
Job Code:
R-28382
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Global Safety Officer (GSO) serves as safety expert for the Biosimilar development products, establishing the strategy, direction, and priorities of pharmacovigilance activities.  The GSO is accountable for the product safety analyses and ensuring subject case reporting for assigned development products.

Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development involves a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product.

Key Activities

Applicable tasks may vary by product(s) assigned.  The activities can be delegated to CRO or Safety Scientist while remaining accountable of the activities.

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

Accountable for the Development and maintenance of safety

Identify relevant data and conduct benefit-risk evaluation

Clinical trial safety:

Develop a strategy for updating safety-related portions of Investigator's Brochure and

Informed Consent Form

Analyze safety data from clinical studies and review clinical study reports

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

Signal detection, evaluation, and management:

Evaluate safety signal detection findings and determine a need and develop a strategy for further analysis

Presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body

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, DSUR)

Review and approve periodic safety reports

Marketing applications and other regulatory filings:

Review and approve filing documents relevant to drug safety

Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings

Prepare for and attend health authority meetings involving patient safety 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

Participate in inspections and audits

Requirements

Basic Qualifications

MD or DO 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

Preferred Qualifications

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

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

Previous management and/or mentoring experience

Processes and regulations for pharmacovigilance and risk management

Advanced understanding of interfaces across various pharmacovigilance and risk management processes

Drug development and lifecycle management

Product and disease state knowledge

Internal organizational and governance structure

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

Ability to analyze and interpret complex safety data

Ability to convey complex, scientific data in an understandable way

Basic skills in application of statistical and epidemiological methods to pharmacovigilance

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)

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

HJUS2016

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