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Associate Medical Director, Safety Science - Remote

Posted 3 weeks ago
All others
Full Time
USA

Overview

The Associate Medical Director of Safety Science provides medical expertise to support safety surveillance activities for assigned products. You will contribute to pharmacovigilance (PV) operations, perform medical safety assessments, assist with regulatory activities, and support the implementation of safety monitoring practices. This role offers the opportunity to develop clinical and regulatory expertise while ensuring patient safety and supporting product development goals.

In Short

  • Support safety physician activities for assigned products under medical director guidance
  • Assist with safety signal detection and evaluation processes
  • Review individual case safety reports (ICSRs) and contribute to medical assessments
  • Support medical interpretation of safety data and causality evaluation activities
  • Attend safety review meetings and contribute to cross-functional safety discussions
  • Assist in the execution of pharmacovigilance activities for assigned products
  • Support risk management plan implementation and monitoring activities
  • Contribute to benefit-risk evaluation processes under supervision
  • Collaborate with clinical teams on safety-related activities
  • Assist in preparing safety content for regulatory documents

Requirements

  • You hold an MD or equivalent medical qualification (active license to practice preferable but not required)
  • You bring 2-5 years of pharmaceutical industry PV experience or relevant clinical experience
  • You have basic understanding of regulatory processes
  • Good understanding of global PV regulations and guidelines
  • Basic knowledge of statistical approaches for safety data evaluation
  • Familiarity with signal detection concepts and safety assessment methods
  • Understanding of benefit-risk evaluation principles
  • Strong communication skills for interacting with diverse teams
  • Ability to work effectively under supervision while taking initiative
  • Commitment to continuous learning and professional development

Benefits

  • Opportunity to develop clinical and regulatory expertise
  • Support patient safety and product development goals
  • Collaborate with cross-functional teams
  • Engagement in professional development and training opportunities
BioMarin Pharmaceutical logo

BioMarin Pharmaceutical

BioMarin Pharmaceutical Inc. is a global biotechnology company founded in 1997, dedicated to transforming genetic discoveries into innovative medicines that enhance human health. With a strong focus on understanding the underlying causes of genetic conditions, BioMarin develops transformative therapies for patients with significant unmet medical needs. The company prides itself on its expertise in genetics and molecular biology, fostering a collaborative environment that empowers its teams to pursue bold scientific advancements. BioMarin's diverse pipeline includes commercial, clinical, and preclinical candidates, aiming to be first-to-market or provide substantial benefits over existing treatments.

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