Randstad Drug Safety Scientist in Rockland, Massachusetts

Drug Safety Scientist

job details:

  • location:Rockland, MA

  • salary:$40 - $55 per hour

  • date posted:Monday, March 12, 2018

  • job type:Temporary

  • reference:S_623149

job description

The Drug Safety Scientist is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety Office. This includes oversight of vendor activities and performance of key activities specified by the Food and Drug Administration. Tasks have to be performed independently and require specific expertise by a health care professional to ensure full compliance with all relevant global and local regulatory requirements and company standards. This includes:

Product safety surveillance

  • Handling of all local safety information, including collection, registration, and transmission to GPS as applicable in a timely manner

  • Oversight of vendor handling local safety information including collection, registration and transmission to GPS as applicable in a timely manner

  • Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner

Reporting to local Health Authorities and Ethics Committees

  • Determining medical relevance of new information received for follow up reports in order to determine reportability to FDA

  • Monitoring of appropriate ARISg workflows to ensure timely submission of expedited ICSRs to FDA

Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries

-Supporting the LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept

-Ensuring local clinical trials comply with global standards and FDA requirements

Patient Safety US Phone Line

  • Log onto Patient Safety US phone line to receive incoming calls of potential adverse event reports and document information according to approved standards.

Working hours: 8:30 - 5:00pm


Competencies and Skills:

  • Ability to work in intense, fast paced, matrixed, multinational work environment

  • Ability to effectively communicate with employees, colleagues, and global counterparts

  • Good understanding of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)

  • Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands

  • Proven ability to follow instructions/guidelines, work independently and takes ongoing initiative

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