PV & RA Senior Specialist
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!
Position Overview: Basic Functions & Responsibilities
The Senior Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics. The Senior 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 Sr. Specialist is also responsible for other activities (as delegated/assigned by their Manager) which may include but are not limited to: management and negotiation of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, local initiatives, SOP management, local training, communication of safety issues, developing product registration plans and strategies, people development, or special projects and is able to work on these delegated activities with minimal supervision.
The Sr. Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. In the absence of their Manager he/she is responsible for managing all day-to-day activities of the PV and RA department and serves as their back-up.
- Serves as the deputy to the local responsible PV person for the country, where applicable.
- Serves as the back-up to the PV and RA Country Lead / Associate Director in their absence and presence (as required).
- 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
- Responsible for development of product registration plans & strategies and working cross-functionally to review &communicate the registration strategy with management oversight
- Responsible for 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
- Labeling and artwork:
- Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
- Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
- 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.
- Serves as SME and 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.
- May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
- 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.
- Develops and maintains local PV and RA controlled documents (i.e., SOPs, training materials) ensuring that they are keptcurrent16.Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Leads the training of PV and RA staff (including maintenance of the local training matrix and onboarding plans)and supports the required training of the local company staff, distributors, vendors, business partners including training documentation.
- May be assigned responsibility for ensuring PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of BDLM with respect to local and regional contracts.
- May be assigned leadership and/or contribution to the maintenance of regulatory licenses including, but not limited to, import, distribution, Medical Device.
- May be assigned leadership and/or contribution over drug shortage management and regulatory requirements for reporting. Support and collaborate with Head Quality Assurance to avoid supply constraints and ensure constant audit-readiness.
- May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally
- Serve as the point of contact for the local Health Authority for PV and Regulatory related questions from the Health Authorities.
- 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
- Participate on local company committees and councils (as appropriate) for matters impacting PV and RA
- Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as review of promotional material.
The incumbent must have a B. Pharm degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language. He/she should have a minimum of 3 years of industry experience in in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV/RA regulations within his/her assigned country and be an expert in PV & RA processes/activities. The Sr. Specialist is expected to have strong communication and time management skills and can work independently with minimal supervision.
Skills: Primary skills include but are not limited to:
- Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Communication Skills: Demonstrates strong communications skills to convey and receive information in English and local language. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills.
- Problem Solving: Demonstrates skills in problem solving using creative thinking, gathers data from appropriate stakeholders and ability to respond to new complex situations and influence organization direction.
- Strategic Thinking: Demonstrates strong skills to drive change that enhances processes within the company or cross-functionally within MRL/MMD/GHH that improve quality and /or add value to the business.
- Project Management: Demonstrates strong 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 some management oversight and to determine when escalation of issues is necessary.
- Business Operations/Knowledge of Field: Demonstrates knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
- Regulatory and Compliance Management: Demonstrates knowledge of PV and RA regulations and regulatory trends.
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.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At Organon, we all belong. We embrace diversity and give it a voice.
Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
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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