Pharmacovigilance Quality & Training Specialist

Company: Organon & Co
Location: Stamford
Posted on: November 23, 2022

Job Description:

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!



Organon is a new company with the need to streamline processes and improve comprehensive overview on the pharmacovigilance (PV) system, to monitor quality and compliance, as well as to collaborate successfully within the organization and with business partners.



The PV Specialist, Quality and Training will support the management and quality of procedural documentation wherein procedures are updated and quality by design is incorporated into the SOP update process. This role will also support the maintenance of the Pharmacovigilance System Master File (PSMF) which will support product registration, renewal and provide an overview of Organon's PV System. The PV Specialist will also maintain a robust PV Training system along with the Adverse Event reporting training course.



This position can be fully remote



Primary Responsibilities:



* Procedural Document management, update, and quality review





* PSMF review and update





* Maintenance of PV System training plans Management of Company-wide Pharmacovigilance Training (Adverse Event and Product Quality Complaint Reporting)





* Participate in or support any other GPSS or OR&D projects or initiates as needed





* Any responsibilities or tasks as assigned by management







Procedural Document management, update, and quality review:



* Coordinate procedural documentation management (lifecycle, ad hoc, and routine review and maintenance of SOPs)





* Provide technical writing support in update of SOPs Perform quality review of documents





* Keep records for continuous improvement activities





* Coordinate with quality for change control activities







PSMF review and update:



* Support Quarterly publication of the PSMF





* Liaise with Subject Matter Experts across multiple disciplines





* Understand GVP Module 2 requirements and regulations for updating PSMF





* Have thorough PV knowledge and experience to support PSMF updates





* Support local PSMF publication and liaise with Local Safety Officers





* Quality checks on PSMF content and inspection readiness (ad hoc updates for inspections and audits)







Maintenance of PV System Training Plans:



* Support Maintenance of PV Training Plans impacting GPSS (including CSO and CMO)





* Development of training material, assessments, and courses within the Learning Management System





* Perform maintenance activities to update curricula, learning items, and keep training plans current





* Generation of metrics, compliance checks on training completion (weekly, monthly, or ad hoc)







Management of Company-wide PV Training:



* Support the implementation of company- wide Pharmacovigilance training (Know to Report AE / PQC Reporting training course)





* Follow up with internal and external stakeholders to ensure completion of training and implementation of training within team matrix





* Generation of monthly metrics to review course completion





* Participate in relevant meetings for enterprise -wide trainings





* Review course content and material for update semi-annually







Education Minimum Requirements:



* Bachelor's degree in a life science/healthcare/pharmaceutical related field







Required Experience and Skills:



* Experience in pharmacovigilance, ICSR processing and regulatory affairs





* Understanding and experience in PV regulations





* Experience with GVP Module II and management of PSMF





* Administration, review, and update of training management plans and implementation via the LMS





* Leadership skills in working with all levels of management and consulting with key business stakeholders





* Excellent writing and verbal communication skills





* Problem solving ability, and analytical skills





* Strong knowledge base of PV regulations, in-depth understanding of business process, as well as safety systems





* Fluent in written and spoken English







Secondary Language(s) Job Description



* Understanding and experience in PV regulations

* Experience with GVP Module II and management of PSMF

* Administration, review, and update of training management plans and implementation via the LMS

* Leadership skills in working with all levels of management and consulting with key business stakeholders

* Excellent writing and verbal communication skills, problem solving ability, and analytical skills.

* Strong knowledge base of PV regulations, in-depth understanding of business process, as well as safety systems

* Fluent in written and spoken English



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 and New York City Positions: to request this role's pay range and benefits, email: jcnycpayact@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:



Regular



Relocation:



No relocation



VISA Sponsorship:



No



Travel Requirements:



10%



Flexible Work Arrangements:



Remote Work



Shift:



1st - Day



Valid Driving License:



Hazardous Material(s):



Number of Openings:



1

Keywords: Organon & Co, Stamford , Pharmacovigilance Quality & Training Specialist, Other , Stamford, Connecticut