Safety Scientist-Team Leader, Pharmacovigilance

This position is responsible for the day to day activities of the team; manages resources, workload quality and metrics; provides updates to senior management on project progress.  This person is knowledgeable regarding regulatory requirements, product information and is a subject matter expert on areas of responsibility.

Essential Duties and Responsibilities

  • Initiates and manages client programs and acts as the single point of contact with the client
  • Prepares the Safety Management Plan (SMP) and other program specific plans
  • Oversees the receipt of safety related information from the client or CRO via telephone, fax, email, etc., from healthcare professionals, study coordinators, allied health personnel, patients, consumers, medical literature and other sources
  • Provides guidance to Safety Scientists on triage, coding, assessment queries, aggregate report scheduling
  • Ensures follows up information is requested on relevant reports within required timelines
  • Performs case processing activities
  • Manages/performs data cleaning activities in accordance with aggregate report calendars
  • Contributes to the preparation of metrics and custom reports for clients
  • Manages the preparation and distribution of SUSAR line listings
  • Oversees and/or implements the generation of queries to the sites for clarification and reconciliation of adverse event reports
  • Supports the Clinical Operations teams with respect to safety related issues as required
  • Oversees reconciliation of clinical and safety databases
  • Works with clients to ensure the provision of client specific training
  • Assigns resource for the evaluation and validation of safety systems; (user acceptance testing)
  • Other duties as assigned by management

Knowledge, Skills and Abilities

  • Medical background:  in Nursing, Pharmacy/PharmD., or equivalent is required
  • Prior experience in CRO or Pharma/Biotech safety department, minimum four (4) years’ experience is required
  • Familiar 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 health authorities, Pharmacovigilance Safety Data Exchange Agreements 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
  • Fluent in English
  • Good written and verbal communication skills
  • Demonstrated Good Documentation Practices
  • Must have valid driver’s license

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

Download job description here