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Associate Director, Consumer Safety Science

External
gsknch logoGsknch · - New Jersey
Full-timeHybridToday
AgileNegotiationProcess ImprovementRisk Management
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About the role

In line with a risk-proportionate framework for product vigilance, the Associate Director, Consumer Safety Science is accountable for defining and developing the safety strategy for R&D innovation projects, as well as maintenance of business activities for medium to high-risk products. The position holder will: Develop safety strategy for medium to high-risk products within the assigned therapeutic category and/or business unit. Ensure that strategic R&D planning is aligned with safety objectives. Ensure effective integration, analysis and interpretation of safety information from all sources, including internal and external clinical and post-marketing data. Present safety strategy to management at key internal forums. Demonstrate and display confidence and credibility.

Responsibilities

  • Ensure a fit-for-purpose approach for safety inputs into maintenance of business activities.
  • Conduct proactive signal detection and management activities for assigned products within respective therapeutic category and/or business unit. Make recommendations to safety management on prioritisation, assessment and escalation of safety signals.
  • Manage implementation of risk minimisation activities in fit-for-purpose manner, including umbrella brand framework and product labelling updates.
  • Evaluate safety issues related to product defects at manufacturing sites.
  • Provide safety expertise into regulatory documents and responses to boards of health.
  • Provide safety inputs in due diligence activities through development of safety assessments and recommendations.
  • Contribute to process improvement initiatives within Consumer Safety and broader organisation.
  • Train, coach and mentor safety associates in the scientific aspects of safety evaluations, signal detection and risk management methodologies.
  • Why you?

Requirements

  • Advanced degree in life sciences (e.g., biomedical sciences, medical/health sciences), pharmacy, nursing, or a related discipline.
  • 5 years+ experience in similar role with extensive knowledge in pharmacovigilance.
  • In-depth knowledge in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes.
  • In-depth knowledge of relevant regulations and methodologies applicable to safety evaluation & risk management activities.
  • Knowledge of the therapeutic areas in consumer healthcare, including OTC medicines, wellness products (such as nutrition and cosmetics), pharmaceuticals, medical devices (a plus), or related disciplines.
  • Medical and drug terminology and good understanding of pharmacology.
  • Strong medical writing skills and computing skills.
  • Doctorate degree (PhD) in life sciences, ; Doctor of Pharmacy (Pharm D), Doctor of Medicine (MD or internationally recognized equivalent), or Doctor of Osteopathic Medicine (DO).
  • Demonstrated experience supporting wellness products
  • Additional experience of product safety related disciplines (e.g., clinical development, medical affairs, regulatory) preferred.
  • Professional qualification as healthcare professional, e.g., Pharmacist may be advantageous.
  • Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant information and understanding of the wider context.
  • Proven ability to train, coach and mentor.
  • Ability to manage and co-ordinate tasks, projects and processes across a large organisation.
  • Effective communication skills: ability to present complex data in a clear and concise manner.
  • Effective negotiation and influencing skills.
  • Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
  • Contributes innovative ideas to address new issues or improve a

Benefits

Health insurance

Additional Information

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.


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