Pv & Ra Senior Specialist

15 hours ago

Johannesburg, South Africa Organon Full time

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 mínimal 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.

**Primary Activities**:

- 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
- 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.Proactive

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