Regulatory Affairs and Pharmacovigilance Specialist

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!

Job Responsibility

• Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
• Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and forwarding of information to the Data Management Center. He/she also performing ICSR acknowledgments and reconciliation activities.
• Responsible for execution of local PV and RA processes and activities in alignment with PV and RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
• Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
• Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
• Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable
• Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements
• Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
• Supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
• Participates in and supports audits of contractual partners/vendors as necessary.
• Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV and RA data and evaluates processes for potential improvement in efficiency and effectiveness.
• May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and ARMMs if applicable.
• Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.
• Support assigned project from RAPV Lead if applicable.
• Support and maintain renewal GMP Clearance for Organon products.
• Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards as assigned product.
• Contributes in the maintenance of regulatory licenses for Therapeutic Products and Medical Device.

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.

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:R510730