Specialist Regulatory Affairs and Pharmacovigilance
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 are 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 will 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 is going to be an exciting future—come be a part of it!
About the role
The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: a review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies.
Execution of country PV and RA processes and activities in alignment with PV and RA systems and their associated Quality Management systems, following department SOPs, company Policies and Procedures and country legislation.
Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities, life-cycle management of authorized products and post-approval activities, including but not limited to artwork management.
Intake management of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs), product quality complaints (PQCs) and serialization alerts including tracking and translation to English and forwarding of information to the Data Management Center.
Daily pharmacovigilance activities including but not limited to adverse events case management, case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
Filing, storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
Support in local RA and PV audits and inspections including readiness activities, support with audits of contractual partners/vendors as necessary and support with other audits/inspections activities including the development of CAPAs in response to findings/observations.
Support drug shortage management and regulatory requirements for reporting, including cross-functional collaboration.
Role requirements and qualifications:
You have a health, life science, or medical science degree or equivalent by education/experience and are fluent in English (written and spoken) while proficient in the local language.
You have a minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs and you have a general knowledge of PV/RA regulations within assigned country and you are an expert in PV & RA processes/activities.
Primary skills include but are not limited to:
Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals.
Communication Skills: Demonstrates good communication skills to convey and receive information in English and the local language.
Problem Solving: Demonstrates good skills in problem-solving
Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations.
Decision Making: Demonstrates strong skills to utilize knowledge, networks, and data to make rapid and appropriate decisions with management oversight and to determine when escalation of issues is necessary.
Secondary Language(s) Job Description:
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.
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Number of Openings:1