Executive Director, Drug Safety

Organon

. Set and implement the overall safety strategy and procedures for an assigned therapeutic-area product portfolio .

Posted 10/14/2026full-timePlymouth Meeting • Pennsylvania • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global pharmacovigilance regulations and risk management, with a strong focus on safety strategy implementation and cross-functional collaboration. Proven leadership in managing teams and driving compliance in pharmaceutical safety processes.

Highest-signal resume keywords

Global Pharmacovigilance ExperienceRisk Management PlanningBenefit-Risk AssessmentPeople ManagementRegulatory Interaction

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceSignal DetectionAggregate Safety ReportingPost-Marketing SurveillanceClinical Development OversightSafety Science ProcessesICH RegulationsGVP RegulationsGCP RegulationsFDA Regulations

Soft Skills

Analytical SkillsProblem-SolvingCommunication SkillsStakeholder ManagementOrganizational Skills

Certifications & Qualifications

Medical Degree (MD or Equivalent)

Industry Keywords

Women's HealthPharmacoepidemiologyHealth AuthoritiesRegulatory AgenciesGlobal Matrix Environment

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Set and implement the overall safety strategy and procedures for an assigned therapeutic-area product portfolio
Lead global pharmacovigilance and risk-management strategies for marketed products and studies
Lead interactions regarding product safety issues with Organon governance committees and regulatory agencies
Chair and participate in cross-functional safety governance committees and decision-making boards
Partner with Regulatory, Medical Affairs, Clinical Development, and other stakeholders
Oversee signal detection, benefit-risk evaluations, risk-management plans, aggregate safety reporting, and post-marketing surveillance
Serve as the primary safety representative for Health Authorities, external partners, and vendors
Ensure compliance with global pharmacovigilance regulations, industry standards, and internal policies
Provide scientific leadership, mentorship, coaching, training, 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
Own assigned core safety-science processes and liaise across GPSS teams for PV-system implementation, maintenance, and issue resolution

Requirements

What you’ll need

Medical Degree (MD or equivalent)
10+ years of pharmaceutical industry experience, including significant global pharmacovigilance and drug safety experience
Deep knowledge of global pharmacovigilance regulations, including ICH, GVP, GCP, FDA, and EMA requirements
Experience in benefit-risk assessment, signal management, risk management planning, and aggregate safety reporting
Strong scientific, medical, and pharmaceutical expertise 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
Fluency in English
Specialty training in Women's Health, Internal Medicine, Cardiology, Neuroscience, or related field preferred
Experience in Women's Health and/or Pharmacoepidemiology preferred
US and PR residents only
Ability to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites

Benefits

Comp & perks

Retirement savings plan
Paid vacation and holiday time
Paid caregiver/parental and medical leave
Medical, prescription drug, dental, and vision coverage
No relocation
Equal Opportunity Employer committed to inclusion, innovation, and belonging