Senior Scientist/Team Lead - Aggregate Reporting

1 month, 1 week ago
Full-time
Senior
Project and Program Management
ClinChoice

ClinChoice

ClinChoice is a leading full-service contract research organization (CRO) that provides high-quality solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer products sectors, focusing on accelerating the development and ...

Professional Services
1K-5K
Founded 1995

Description

  • Author aggregate safety reports for medicinal, non-medicinal, medical device, and cosmetic products for submission to health authorities.
  • Plan report timelines, identify stakeholders, request contributions, and coordinate data collection for reports.
  • Review safety data and verify the completeness and correctness of stakeholder inputs.
  • Perform aggregate reviews of post-marketing cases and assess potential impact on product safety profiles.
  • Draft reports in required templates, address review comments, and submit high-quality final reports to sponsors.
  • Support literature reviews and signal management activities, including signal detection, validation, assessment, and documentation.
  • Maintain awareness of applicable global aggregate reporting regulations and guidance.
  • Perform quality reviews of peer-prepared reports for accuracy, completeness, and sponsor compliance.
  • Monitor health authority websites for safety updates, labeling recommendations, signal evaluations, and risk minimization measures.
  • Mentor junior team members, support onboarding, conduct refresher training, and provide functional guidance.

Requirements

  • Bachelor’s or Master’s degree in life sciences or a healthcare discipline, or equivalent.
  • 5-8 years of relevant experience in the domain/business requirements.
  • Advanced knowledge of global regulatory requirements, drug safety, and regulatory guidelines.
  • Familiarity with drug safety case management and safety databases such as ARGUS and ARIS G.
  • Strong verbal and written communication skills in a global environment.
  • Ability to work independently with minimal guidance and manage multiple deliverables.
  • Experience with aggregate safety reporting and related regulatory submissions (preferred).
  • Experience reviewing safety data, signal management, or literature reviews (preferred).

Interested in this position?

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