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Ra & Pv Specialist\\ Cenca Region
hace 1 mes
**Description of The Position**
Responsible for all post-marketing surveillance and Regulatory Affairs submission requirements and post-marketing surveillance activities for their assigned product portfolio according to Organon policies and procedures in Central America and Caribbean countries, as applicable.
**Responsibilities**
The Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics.
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.
Responsible for execution of local post-marketing surveillance and Regulatory Affairs processes and activities in alignment with post-marketing surveillance and Regulatory Affairs systems and their associated Quality Management System, following department Standard Operating Procedure, company Policies and Procedures and country legislation.
- Acts in full compliance with global and local Standard Operating Procedure and reporany deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions locally for non-compliance issues.
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality post-marketing surveillance and Regulatory Affairs data and evaluates processes for potential improvement in efficiency and effectiveness.
- Demonstrate knowledge of, and ensure compliance to, all relevant regulatory and post-marketing surveillance legislation and internal procedures. Proactively identify procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Set quality standards, by participating in the development of appropriate SOPs and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, post-marketing surveillance, and QA actions etc., per requirements of the internal policies and applicable local regulations.
- Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.
- Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information.
- Work on continuing improvements and simplification.
- Development and maintenance of a consolidation work plan and tracking system.
Regulatory:
- Responsible for all daily RA processes and activities within the countries covered by the country operation as required.
- Establish and maintain a strategic partnership through effective, timely, communication with Area Commercial, Medical and Regulatory for all products.
- Maintain product license in compliance with market supply, and local authority expectations. Ensure alignment with all applicable change control documents.
- Coordinate and assure a timely review and approval of the Artworks for packaging materials for all products.
- Support to Sales Department with Regulatory Documents (GMP certificates, Bioequivalence letters and others) for Tender Bids.
- Support the others regulatory process as required by the Manager.
Post-marketing surveillance:
- Responsible for all daily PV processes and activities within the countries covered by the country operation as required.
- Responsible for day-to-day adverse events case management including case intake and follow up activities in accordance with Global Post-marketing surveillance procedures and country regulations. Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center.
- Perform ICSR acknowledgments and reconciliation activities for post-marketing surveillance 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/ Post-marketing surveillance legislations.
- Responsible for local preparation and submission to the Health Authority of the aggregate report in countries under scope.
- Supports local post-marketing surveillance audits and inspections including readiness activities and supports other audits/inspections including the development of corrective actions and preventive actions in response to findings/observations.
- Provide support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable.
- Supports audits of contractual partners/vendors as necessary.
- Develop and maintain local post-marketing surveillance-controlled documents (i.e., SOPs, training materials
