Clinical Safety Scientist

Clinical Safety Scientist
  • $1 - $49.95 per Hour
  • Temporary
  • Warren NJ, US Warren SOMERSET US 07059
Job Ref: JO000115652
Sector: Science
Sub-sector: Food & FMCG
Date Added: 15 April 2021

Clinical Safety Scientist

Safety Governance and Risk Management activities
• Contributes to regulatory benefit-risk assessments, authors Risk Management Plans for designated
products for submission to regulatory authorities
• Provides support and input into Clinical Development planning activities, as required
• With guidance, represents SERM on cross-functional project teams
• Reviews and may provide technical approval for investigator brochures, protocols, informed consents,
final study reports and external data monitoring committee charters. Ensures prompt notification to SERM
Head of any reviewed protocols that are identified as potential PASS
• Ensures that risk-reduction strategies are implemented appropriately in in relevant documents such as
umbrella branding assessments and/or product labelling
Signal Detection, Evaluation and Labeling:
• Performs signal detection for assigned products using available methodologies (e.g. On-Line Signal
Management Tool, literature review, individual case awareness tool)
• Uses appropriate sources of information and database searches to retrieve relevant data for evaluation
of signals. Analyses safety data and discusses the results with the PV Team Leader / SERM physician
and other key stakeholders
• Presents on labeling recommendations to CH Global Labelling Committee and other relevant GSK
boards, in partnership with SERM physician
• Produces regulatory supporting documentation for labeling updates
• Produces accurate and fit for purpose evaluation documents with clear conclusions in response to
internal or regulatory authority requests for safety data. Provides safety input into regulatory requests for
local label deviations from the company core data sheet, in partnership with the SERM physician
• Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue;
communicates with the SERM physician / PV Team Leader and/or Manufacturing; and documents
Regulatory Reports and Submissions:
• Authors periodic regulatory documents (PBRERs, DSURs) according to the agreed process and
Supports the Local Operating Companies by preparing license renewal documentation (e.g. PBRER
addenda line listings, clinical overviews, summary bridging reports), as required for each market
• May author the SERM safety contribution to global regulatory submissions for new products,
formulations or indications, with strategic guidance from more senior personnel
Other SERM Activities:
• May assist in production of SERM component and/or review of Safety Data Exchange Agreements, and
escalates any deficiencies to the PV Team Leader to ensure quality and integrity of agreement
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• May act as a member of a process improvement initiative team within pharmacovigilance function
• Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures
quality and integrity of issue/event being escalated

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

20/01/2022 12:00:00
USD 1.00 49.95 Hour
Contact Consultant:
Angela Leick

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