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Area/Local Safety Officer Consultant

ClinChoice
Contract type
One-time
Work mode
Remote
Experience
Mid-level · 2+ years

Job description

A 12-month contract (with possible extension) for an Area/Local Safety Officer Consultant working directly for one client of ClinChoice, a global CRO. The role ensures local operating company pharmacovigilance and safety activities comply with local regulations and company policies.

At a glance

Employment
Contract
Work mode
Remote
Languages
English – fluent, French

What you'll do

  • Perform the quality check of the PV cases and ensure that the English translation has been properly performed
  • Keep up to date a local tracker of the individual safety reports
  • Be the subject matter expert at local level on the case management activities
  • Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams
  • Establish and maintain local indicators on the compliance of the safety reports submission
  • Oversee the training of the local employees and the business partners; maintain KPI and present them during regular team meetings
  • Perform regulatory monitoring for impact on vigilance activities and responsibilities
  • Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders)
  • Maintain oversight of proper identification of local literature articles for AE reporting as required
  • Perform reporting/submissions of safety reports/updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable
  • Support Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals
  • Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements and collaborate with the global team to implement process changes
  • Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective CAPAs
  • Perform document management and archiving as required
  • Ensure current knowledge of all relevant company procedures and training
  • Develop, update, and implement local procedures to ensure compliance with Client's global procedures and national requirements
  • Support in local health authority inspections and audits conducted locally, including responding to queries and collaborating with the global team to develop and implement CAPA plans
  • Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information
  • Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)
  • Perform other agreed tasks assigned by manager

What we're looking for

  • Education: health care science professional or equivalent training
  • Significant training in data management with strong IT skills
  • 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager)
  • Fluent in English
  • French as a mother tongue
  • Excellent communication skills and ability to work with cross-functional teams
  • Rigor is a key skill for this mission

How to get hired

  1. 1Submit CV and receive an acknowledgement
  2. 2Phone interview as the first step

Apply

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About ClinChoice

Global full-service CRO

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

Mission

To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices

Key facts

  • over 4,000 professionals
  • Contract Research Organization (CRO)
  • Over 28 years of proven high-quality delivery and results across all our services
  • Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
  • Below industry average turnover rates

What they value

  • Quality
  • Professional development
  • Supportive culture
  • Diversity and inclusivity