Executive Director, Drug Safety

Organon • Plymouth Meeting, PA

1d

About The Position

The Executive Director, Drug Safety provides strategic leadership for product safety and benefit-risk management across an assigned therapeutic-area portfolio, including medicinal products and/or medical devices. The role sets and implements safety strategies and procedures for post-marketing pharmacovigilance, interventional and non-interventional studies, and clinical development activities, with a focus on scientific assessment and safeguarding patient safety.

The position leads safety-related interactions with Organon governance committees and regulatory agencies, and works across functions to align safety strategies with development, regulatory, medical, and company objectives. It provides scientific guidance, expertise sharing, coaching, and training to Drug Safety Leads, Safety Science Leads, and Safety Scientists; owns assigned core safety science processes; and supports pharmacovigilance system implementation, maintenance, and issue resolution. The role also manages and develops staff within the Safety Science Therapeutic Areas of the Global Pharmacovigilance and Safety Science Department.

Requirements

• Medical Degree (MD or equivalent).
• At least 10 years of pharmaceutical industry experience, including significant global pharmacovigilance and drug safety experience.
• Deep knowledge of global pharmacovigilance regulations and requirements, including ICH, GVP, GCP, FDA, and EMA.
• Experience in benefit-risk assessment, signal management, risk management planning, and aggregate safety reporting.
• Strong scientific, medical, and pharmaceutical expertise, with experience supporting clinical development and marketed products.
• Proven people-management and leadership experience, including leading teams in a global matrix environment.
• Experience interacting with Health Authorities and representing organizations in regulatory discussions.
• Excellent analytical, problem-solving, communication, and stakeholder-management skills.
• Ability to influence across functions, build partnerships, and drive strategic initiatives.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
• Fluency in English.

Nice To Haves

• Specialty training in Women's Health, Internal Medicine, Cardiology, Neuroscience, or a related field.
• Experience in Women's Health and/or Pharmacoepidemiology.

Responsibilities

• Provide strategic leadership for product safety and benefit-risk management across an assigned therapeutic-area portfolio.
• Lead the development and execution of global pharmacovigilance and risk management strategies for marketed products and studies.
• Chair and participate in cross-functional safety governance committees and decision-making boards.
• Partner with Regulatory, Medical Affairs, Clinical Development, and other stakeholders to align safety, development, and business objectives.
• Oversee signal detection, benefit-risk evaluations, risk management plans, aggregate safety reporting, and post-marketing surveillance activities.
• Serve as the primary safety representative for interactions with Health Authorities, external partners, and vendors.
• Ensure compliance with global pharmacovigilance regulations, industry standards, and internal policies.
• Provide scientific leadership, mentorship, and people management for Safety Physicians and Safety Scientists.
• Support inspections, audits, vendor oversight, and continuous improvement of pharmacovigilance processes.
• Provide safety oversight for clinical development activities and post-authorization safety studies.
• Lead interactions concerning product safety issues with Organon governance committees and regulatory agencies, including participation in Asset teams, RMSTs, SRC, LEAD/LAST, NORSAP, and other safety decision-making bodies.
• Own assigned core safety science business processes and liaise across GPSS teams on pharmacovigilance system implementation, maintenance, and issue resolution.
• Manage and develop staff in the Safety Science Therapeutic Areas at the GPSS Department.

Benefits

• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree