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Aerotek Remote Global Safety Officer in Thousand Oaks, California

Description:

-Candidate can be fully remote, open to any US time zone. Must be within US.

  • MD required

Compensation: $100-150/hour

Benefits: Optional Medical, vision, dental, 401k benefits are provided a la carte

The contract Global Safety Officer (GSO) with work with the TAH to provide safety oversight for assigned products. The contract GSO leads the Safety Analysis Team (SAT) and Global Safety Team (GST) with input from the TAH.

Key Activities Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the contract Global Safety Physician while remaining accountable for the activities (e.g. validate a signal).

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

*Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information (DCSI), 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

*In conjunction with the TAH, the contract GSO review relevant clinical trial or study required documents as they pertain to safety.

*Develop a strategy as needed for updating safety-related portions of Investigators Brochure and Informed Consent Form

*Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs)

*Analyze safety data from clinical studies and review clinical study reports as needed

*In conjunction with the TAH, the contract GSO will develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees

In conjunction with the TAH and assigned GSS, the contract GSO will provide Signal detection, evaluation, and management input for assigned products. This includes working with the TAH and GSS to :

*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 in conjunction with the TAH and assigned GSS lead a 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, and in conjunction with the TAH and GSS present the data to the executive level cross-functional decision-making body

Create safety assessment reports

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

Risk management and minimization activities

*Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document

*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

New drug 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

*Review and assist in development of Pediatric Investigation Plan (PIP)

*Prepare for and attend health authority meetings involving patient safety issues

Safety Governance Leadership

*Participates in safety governance meetings per Standard Operating Procedures and Manuals in conjunction with the TAH and assigned GSS)

Amgen commercialization process

*Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams

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 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

KNOWLEDGE

*Serves as a technical authority within the organization

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

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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