Senior Safety Scientist/Senior Drug Safety Specialist

Responsible for receiving safety related information via telephone calls, faxes, e-mails, web portals, etc., from Sponsors, CROs, healthcare professionals, study coordinators, allied health personnel, patients, caregivers and other parties reporting potential adverse events; entering data into safety database; preparing draft MedWatch and CIOMS I forms; following up on all SAE reports within required timelines; coding safety data using MedDRA dictionary; coding medications using WHO-Drug; coding medical history using ICD-9 or other coding scheme; overseeing and/or implementing the generation of queries for clarification and reconciliation of adverse event reports; assisting with the preparation of Safety Management Plans (SMP) and other project plans as necessary; and serving as a Subject Matter Expert (SME) as applicable.

Essential Duties and Responsibilities

  • Receives safety related information via telephone calls, faxes, e-mails, web-portals, etc., from Sponsors, CROs, healthcare professionals, study coordinators, allied health personnel, patients, caregivers and other parties reporting potential adverse events • Enters data into safety database
  • Prepares draft MedWatch and CIOMS I forms
  • Follows up on all SAE reports within required timelines
  • Codes safety data using MedDRA dictionary
  • Codes medications using WHO-Drug
  • Codes medical history using ICD-9 or other coding scheme
  • Oversees and/or implements the generation of queries for clarification and reconciliation of adverse event reports
  • Assists with the preparation of Safety Management Plans (SMP) and other project plans as necessary
  • Assists in preparation of monthly adverse event reports for clients
  • Prepares and distributes SUSAR line listings
  • Provides rotating coverage for SAE handling and other essential department functions during non-business hours, weekends, and holidays according to department defined requirements
  • Establishes and maintains auditable safety files in accordance with Good Pharmacovigilance Practice (GVP) and ICH standards
  • Performs file creation, retention and maintenance
  • Supports the Clinical Operations teams with respect to safety related issues as required

Serves as subject-matter expert (SME) as applicable for:

  • Reconciliation of clinical and safety databases
  • Quality control (QC) of safety reports 
  • Preparation of internal SOPs and Working Practice Documents (WPD)
  • Preparation of training materials on safety and participate in staff training
  • Preparation of materials and make proposals and presentations at client meetings
  • Evaluation and validation of safety systems; (user acceptance testing)
  • Preparation of aggregated data reports 

Other duties as assigned by management.

Supervisory Responsibilities:

Provides guidance and mentoring to new department staff.

Knowledge, Skills and Abilities

  • Medical Background: Nursing, Pharmacy/PharmD, or health care related field or equivalent is required
  • Prior experience in CRO or Pharma/Biotech safety department, minimum four (4) years’ experience is required
  • Working knowledge of ICH Guidelines and US CFR 314.80, 312.32; MedDRA and WHO-Drug coding is desirable
  • Knowledge of Good Pharmacovigilance Practices (GVP)
  • Must have valid driver’s license
  • Fluency in both written and spoken English is a requirement
  • Strong computer skills
  • Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing, call center activities, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements is required • Good interpersonal and communication skills
  • Demonstrated Good Documentation Practices

To apply please send resume and cover letter to info@vigilareintl.com

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