Drug Safety Associate in Connecticut (Remote) Job at TriOptus LLC, Stamford, CT

bHZwM0xVazQzRmEyQTNwdHR6ZlEvbFoxR1E9PQ==
  • TriOptus LLC
  • Stamford, CT

Job Description

Position : Drug Safety Associate


Location : Connecticut ( Remote )

Job Description:

  • Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations.

Primary Responsibilities:

  • Perform case processing activities (triage, data entry, report distribution) as required
  • Assess, process, and data enter all AE case types to meet compliance requirements
  • Perform triage on all case types to determine prioritization
  • Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability
  • Select the appropriate as reported causality and company causality
  • Perform all appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
  • Own case narrative - create narrative text as required for medical orientation
  • Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information
  • Perform CRO case QC activities, reconciliation etc as required.
  • Support ICSR submissions and transmissions as needed
  • Work on highest priority or assigned cases using Workflow Management System, or as directed
  • Participate in inspections and audits as identified, including interviews and provision of requested data
  • Meet KPIs/KQIs as designated by client and in compliance with company guidelines and policies
  • Assist in writing late ICSR related deviations and CAPAs, upon request
  • Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within client organization.

Education and Experience Requirements:

  • Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 3 years in Drug Safety Operations role;
  • Experience overseeing CRO teams of case processors preferred
  • US FDA pharmacovigilance inspection experience preferred

Necessary Knowledge, Skills, and Abilities:

  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability - takes ownership of deliverables
  • Possible relevant titles: Seasoned PV lead or QC Associate on a CRO team
TriOptus LLC

Job Tags

Similar Jobs

Powell Watson Automotive Group

Scanning Clerk Job at Powell Watson Automotive Group

 ...Documents that previously filled filing cabinets and took up precious office space can now be quickly and easily scanned into a computer system and retained in a digital format. Our new scanning clerk will work to ensure that documents scanned in this way are accurate... 

Vimo, Inc. DBA GetInsured

Product Designer-$148845 Sr DevOps Eng'r-$172931 Job at Vimo, Inc. DBA GetInsured

Product Designer-$148845 The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below. Sr DevOps Eng'r-$172931 Company: Vimo, Inc. DBA GetInsured Location: Mountain View, CA Position Type: Full... 

Arena Investors LP

Chief Risk Officer Job at Arena Investors LP

 ...investment management firm that seeks to generate attractive risk-adjusted, consistent, and uncorrelated returns by employing a...  ...conventional sources of capital are scarce. We are seeking a Chief Risk Officer (CRO) to join Arena. The newly created role will create a... 

TBWAChiatDay

Marketing Database Manager Job at TBWAChiatDay

 ...requiring a minimum of 2 days a week on site) Position Summary : We are looking for a detail-oriented and data-driven Marketing Database Manager to oversee the management, segmentation, and optimization of our marketing database. This role is critical in ensuring data... 

8x8

Senior Manager, Account Based Marketing (ABM) Campaigns Job at 8x8

 ...Twitter, Facebook and Instagram.Job Summary:We are seeking an experienced and dynamic Senior Manager of Account-Based Marketing (ABM) to lead the development, implementation, and optimization of multichannel ABM programs. This role is pivotal in driving personalized...