Pharmacovigilance Manager

**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
1. Serves as the back-up PV Responsible person/QPPV as required per local PV legislation.
2. Oversees all daily PV processes and activities within the country operation as required.
3. Ensures after-hours coverage and maintains and updates the local PV Business Continuity Plans when needed.
4. Responsible for the monitoring of new/revised HA regulatory information related to PV and for the timely implementation of the new/updated PV regulations.
5. Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country(ies) legislation.
6. Oversees reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact) and vendors/business partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations.
7. Provides support and oversees vendor management such as Patient Support Programs (PSP) and/or Market Research vendor(s), social media related activities, as applicable, before the beginning of the project(s).
8. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
9. 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.
10. 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 and monitors until closure.
11. Participates in and supports audits of contractual partners/vendors as necessary.
12. May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
13. Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
14. Develops and maintains local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.
15. Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
16. Leads the training of PV 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.
17. May be assigned responsible 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.
DEVERES E RESPONSABILIDADES FUNDAMENTAIS / FUNDAMENTAL DUTIES AND RESPONSIBILITIES
18. Ensures appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally, when applicable.
19. 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.
20. Participates on local company committees and councils (as appropriate) for matters impacting PV.
21. Ensures scheduling and submission of aggregate reports (PBRER, DSUR and RMP) according to local PV legislation.
22. Responsible for identifying and communicating potential safety issues to the PV Country Lead, PV Regional Lead and /or Global Safety Headquarters as appropriate, as well as local HA.
23. Responsible for the availability of current organization charts, job descriptions, CVs and training records for all PV staffs.
- The incumbent must have a health, life science, or medical science degree or equivalent by education / experience.
- He/she should have a minimum of 7 years of indu

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