Executive Director, Drug Safety

Organon LLC; Harmonville (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Organon LLC seeks a strategic leader to set and implement the safety strategy for an assigned therapeutic area portfolio, spanning post-marketing pharmacovigilance and safety science. You will drive global PV and risk management, chair governance bodies, and partner with Regulatory, Medical Affairs, and Clinical Development to align safety with business objectives.

You will oversee signal detection, benefit-risk assessments, and regulatory interactions, while mentoring Safety Physicians and

Qualifications

• MD or equivalent with specialty training in Women's Health, Internal Medicine, Cardiology, Neuroscience or related field.
• 10+ years in the pharmaceutical industry with global pharmacovigilance and drug safety experience.
• Deep knowledge of global pharmacovigilance regulations (ICH, GVP, GCP, FDA, EMA).
• Experience in benefit-risk assessment, signal management, risk management planning and aggregate safety reporting.
• Strong scientific, medical and pharmaceutical expertise across clinical development and marketed products.
• Proven people management and leadership in a global matrix environment.
• Experience interacting with Health Authorities and regulatory discussions.
• Fluency in English; experience in Women's Health and/or Pharmacoepidemiology preferred.

Responsibilities

• Provide strategic leadership for product safety and benefit-risk management across an assigned portfolio.
• Lead global pharmacovigilance and risk management strategies for marketed products and studies.
• Chair and participate in cross-functional safety governance committees and 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 and post-marketing surveillance activities.
• Serve as primary safety representative for interactions with Health Authorities, external partners and vendors.
• Ensure compliance with global pharmacovigilance regulations and internal policies.
• Provide scientific leadership, mentorship, and people management for Safety Physicians and Safety Scientists.
• Support inspections, audits, vendor oversight and continuous PV process improvement.
• Provide safety oversight for clinical development activities and post-authorization safety studies.

Skills

Fluency in English

Leadership

Stakeholder management

Analytical skills

Communication

Strategic thinking

Project management

Education

Medical degree (MD or equivalent)

Job description

Job Description

Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants The Position Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a scientific perspective and safeguarding patient safety.

• Leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies e.g., by active participation and contribution to amongst others the Organon Asset teams, Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST, NORSAP and other safety related decision-making governance bodies.
• Build strong relationships with the cross functional teams, to influence and ensure that the development-, regulatory and or medical strategy and procedures are aligned with the safety strategy as well as with company objectives.
• Ensure that the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise, for effective benefit-risk decision-making by guidance, expertise sharing, coaching and/or training of the Drug Safety Leads, Safety scientists leads and Safety Scientists.
• Business process ownership of assigned core safety science processes and liaison between the different GPSS teams for PV system implementation and maintenance as well as issue resolution
• Line-Management, development of staff in the Safety Science Therapeutic Areas at the Global Pharmacovigilance and Safety Science (GPSS) Department.

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 ensure alignment of 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.

Required Education, Experience & Skills

• Medical Degree (MD or equivalent); specialty training in Women's Health, Internal Medicine, Cardiology, Neuroscience, or related field preferred.
• 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 with experience supporting both 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 strong partnerships, and drive strategic initiatives.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Fluency in English.
• Experience in Women's Health and/or Pharmacoepidemiology is preferred.
• Secondary Language(s)

Organon

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

Search Firm Representatives

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only

Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US) Annualized Salary Range (Global) Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

About Us

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.