Associate Director, Consumer Safety Science

HaleonWarren Township, NJ
$156,313 - $214,930Hybrid

About The Position

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.

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.

Nice To Haves

  • 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 approaches to existing operations.
  • Ability to adjust behaviours and priorities based on changing environment.
  • Shows intellectual curiosity, able to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes.
  • Ability to engage in and contribute to the broad R&D organisation with confidence, integrity and professionalism.

Responsibilities

  • Define safety strategy and provide expert safety input to R&D innovation projects for all CH product types (e.g., medicines, medical devices, cosmetics, dietary supplements, digital health projects) within assigned therapeutic category and/or business unit and represent safety function on project teams and other relevant cross-functional forums.
  • 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.

Benefits

  • Generous 401(k) plan
  • Tuition reimbursement
  • Time off programs including 6 months paid parental leave
  • Healthcare programs where the company pays for the majority of your medical coverage for you and your family
  • Discretionary bonus based on the achievement of key business performance
  • Other incentive/recognition programs
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