Clinical Operations

  • location: Cambridge, MA
  • type: Contract
  • salary: $72.83 - $85.68 per hour

job description

Clinical Operations

Safety Review Specialist

Job Summary

This position is a member of the US Local Operating Company Team within Global Drug Safety (GDS). This position supports the LOC team in PV oversight and support of the post-market safety function for the region and may liaise with stakeholders in other functional areas accordingly to ensure that the interests of GDS and the wider 'system of pharmacovigilance' are respected. This role will assist in the workflow of the team, maintain knowledge in all locally - marketed client products and support AE training needs external to GDS. The Safety Associate will support the handling of sensitive customer issues and is expected to exhibit competency when dealing with internal and external customers.

Job Responsibilities

25% of Responsibilities

  • Function as a case owner and process ICSRs. Escalation contact for enquiries coming into GDS. This may include the triage of source documents, assessing case priority, company awareness date, need for and request for follow-up and identifying duplicate cases.
25% of Responsibilities

  • Process Individual Case Safety Reports (ICSRs) through the Case Assessment workflow step and/or the QC-Finalization workflow step to Distribution Closure, adhering to established timelines and SOPs.
15% of Responsibilities

  • May participate in literature review activities related to adverse event reporting.
15% of Responsibilities

  • Code medical terms using standardized medical dictionaries (i.e. MedDRA and WHO dictionaries).
10% of Responsibilities

  • Collaborate with relevant counterparts in the regional and country drug safety functions to facilitate the global exchange of safety information.
10% of Responsibilities

  • Interface with other groups (e.g. Quality, Regulatory Affairs, Marketing, IT, etc.)
Education & Qualifications

  • Required Degree: Associate's or Bachelor's degree for Nursing; Bachelor's degree or Pharm D for Pharmacy
  • Preferred Degree: Nursing: Bachelor's degree; Pharmacy: Pharm D
  • Minimum of 0-2 years experience in pharmaceutical industry
  • 2-3 years of hospital, patient care or equivalent experience
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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