Global Safety Manager - Global Pharmacovigilance Scientist - Cambridge, MA | Biospace
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Global Safety Manager - Global Pharmacovigilance Scientist

Amgen

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Location:
Cambridge, MA
Posted Date:
5/28/2017
Position Type:
Full time
Job Code:
R-36217
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Global PV Scientist Manager works with the Therapeutic Area Safety Teams to perform signal detection and safety assessment activities. This person will also provide scientific and compliance expertise to facilitate a constant state of inspection readiness within 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 Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The PV Scientist Manager contributes under the direction of the Global PV Sr. Scientist or Global PV Scientist Lead to:

Contribute to the planning, preparation, writing and review of non-medical portions of aggregate reports

Work with affiliates and other internal Amgen partners regarding deliverables

Support clinical trial activities by:

  • Review of AE/SAEs from clinical trials
  • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
  • 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

Conduct signal detection, including adverse event data, literature and other sources in collaboration with GSO and according to Amgen Safety Governance process

Evaluate and document safety assessment, and if warranted, prepare safety assessment reports and other safety documents and regulatory responses

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

Assist GSOs and other Senior Scientists in the development of risk management strategy and activities and provides risk management plan content

Assist GSOs to oversee risk minimization activities including tracking and evaluation of activities

Prepare response to regulatory inquiries related to risk management plans and safety queries under the guidance of GSO

Support activities related to new drug applications and other regulatory 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

Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods

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Requirements

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Safety experience

OR

Bachelor's degree and 5 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, RPh, NP or MPH

Clinical/medical research experience

Experience in a biotech/pharmaceutical setting

Pharmacovigilance skills-Beginning knowledge of the following:

Processes and regulations for pharmacovigilance and risk management including:

Drug development and lifecycle management

Product and disease state knowledge

Safety data capture in clinical development and post-market settings

Safety database structure and conventions

MedDRA and other dictionaries used in pharmacovigilance

Signal detection, evaluation and management

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

Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

Ability to convey complex, scientific data in an understandable way

Ability to analyze and interpret complex safety data

Applies knowledge and broad understanding of multiple disciplines

Understands impact of emerging scientific/technical trends and their implications for Amgen