Global Pharmacovigilance Senior Scientist - Cambridge, MA | Biospace
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Global Pharmacovigilance Senior Scientist

Amgen

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Location:
Cambridge, MA
Posted Date:
2/25/2017
Position Type:
Full time
Job Code:
R-32484
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Global PV Senior Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).

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 GPS and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global PV Senior Scientist is responsible for the following:

Directs the planning, preparation, writing and review of portions of aggregate reports

Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products

Supports and provides oversight to staff with regards to safety in clinical trials to review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents

Review of AEs/SAEs from clinical trials

Review standard design of tables, figures, and listings for safety data from clinical studies

Participate in development of safety-related data collection forms for clinical studies

Participate in study team meetings

Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results

Documents work in the safety information management system

Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO

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

Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:  Provides contents for risk management plans; Develop or update strategy and content for regional risk management plans; Assist GSOs to oversee risk minimization activities including tracking of activities; Evaluate risk minimization activity; Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO

Support activities related to new drug applications and other regulatory filings:  Assist GSO in developing a strategy for safety-related regulatory activities; Provide safety contents for filings

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

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Requirements

Basic Qualifications

Doctorate degree and 2 years of Safety experience

OR

Master's degree and 6 years Safety experience

OR

Bachelor's degree and 8 years of Safety experience

OR

Associate's degree and 10 years of Safety experience

OR

High school diploma / GED and 12 years of Safety experience

Preferred Qualifications

RN, PharmD or PA

Clinical/medical research experience

Processes and regulations for pharmacovigilance and risk management

Aggregate data analysis, interpretation and synthesis

Signal detection, evaluation and management

6 years of experience in a biotech/pharmaceutical setting

Previous management and/or mentoring experience

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.