Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

**This position can be 100% remote**

Under the direction and oversight of the Director, Pharmacovigilance (PV) Business Liaison, the Lead Commercial/Marketing PV Liaison is the point of contact for safety reporting support for Commercial and Marketing programs and implements and performs necessary processes to ensure compliance with US FDA safety requirements and regulations and global standardization. The scope of Commercial and Marketing programs includes but not limited to: Patient Support Programs, Market Research Programs, Social Media, Digital Health Solutions, Unregistered Product Supply to ensure consistency and compliance with reporting AEs to our Company.

The Lead is responsible for the review, interpretation and communication of evolving US PV requirements and regulations to impacted stakeholders to ensure the compliant processing of individual case and aggregate safety reporting.

Primary Responsibilities:

• Develop relationships across the enterprise to manage Patient Support Programs, Market Research Programs, Social Media, etc. as it relates adverse experience reporting to ensure consistency and compliance with reporting AEs to the company.

• Provide guidance and support to the Project Owners with reviewing and approving US and global PV plans.

• As needed, partner with the PV Agreements team to ensure vendors engaged have the appropriate PV requirements and PV due diligence completed prior to project implementation.

• Be a mentor and provide support to the Regional PV Operations team and Regulatory Affairs/PV Leads related to local country PV plans, as needed, and to ensure alignment on the approach for AE monitoring and reporting to the Company.

• Perform activities related to the interpretation and review of existing and evolving FDA safety requirements for pharmacovigilance and other relevant regulations and implementation of processes to ensure compliance.

• Leverage expertise across PV Headquarters to review, discuss interpretations, and determine required actions to implement new or revised PV regulations. Manage, assign, track and ensure completion of actions needed as a result of new/revised policy.

• Raise concerns and opportunities to align PV standards.

• Promote global harmonization of processes based on policies.

• Provide content for the ongoing development and expert review of the safety database user manual, standard operating procedures (SOPs), and training material as needed to ensure accuracy.

• Promote understanding and education of safety requirements for pharmacovigilance and other relevant regulations with all of Company’s business units to ensure compliance and patient safety.

• Collaborates internally and externally on processes that ensure compliance with safety requirements for pharmacovigilance and other relevant regulations.

• Collaborate closely with IT/BT and engage team members as appropriate to implement system improvements and updates of PV systems.

• Support and participate in various important pharmacovigilance process, IT and quality initiatives.

• Participate in inspection readiness activities and preparation as needed.

Education Minimum Requirements:

• Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field.

Required Experience and Skills:

• 3-5 years of experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs.

• Knowledge of PV regulations, understanding of business process, as well as safety systems for collections of adverse experiences.

• Understanding of vendor relationships and engagement or managed vendors where adverse event reporting/PV agreements are required.

• Problem solving, conflict resolution and critical thinking skills.

• Excellent presentation, writing and communication skills.

• Effective leadership skills.

• Ability to function with a high degree of autonomy and be a team player.

• Quickly adapt to changes in business priorities and effectively manage competing priorities.

• Must be detailed oriented.

• Proficient in basic Office 365 suite applications.

Who We Are:

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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Residents of Colorado: to request this role’s pay range: email: coloradopayact@organon.com

Jersey City, New York City, Washington State & California Positions: to request this role’s pay range and benefits, email: jcnycpay@organon.com

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

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, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R514435