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Pharmacovigilance and Regulatory Affairs Specialist
hace 2 meses
Organon is seeking a highly skilled Pharmacovigilance and Regulatory Affairs Specialist to join our team in Colombia. As a key member of our Regulatory Affairs and Pharmacovigilance department, you will be responsible for ensuring compliance with local laws and regulations, managing Pharmacovigilance submission requirements, and executing local Regulatory Affairs processes and activities.
Responsibilities- Collaborate with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules to ensure no gap in adverse event reporting and drug safety oversight.
- Responsible for execution of local Pharmacovigilance and Regulatory Affairs processes and activities in alignment with Pharmacovigilance and Regulatory Affairs systems and their associated Quality Management System, following department Standard Operating Procedure, company Policies and Procedures, and country legislation.
- Act in full compliance with global and local Standard Operating Procedure and report any deviations or compliance concerns immediately, assisting in preparing necessary corrective actions and preventative actions locally for non-compliance issues.
- Assist in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality Pharmacovigilance and Regulatory Affairs data and evaluate processes for potential improvement in efficiency and effectiveness.
- Demonstrate knowledge of, and ensure compliance to, all relevant regulatory and pharmacovigilance legislation and internal procedures.
- Proactively identify procedural gaps and challenges and implement 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, pharmacovigilance, and QA actions, per requirements of the internal policies and applicable local regulations.
- Maintain appropriate archives (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.
- Develop and maintain a consolidation work plan and tracking system.
- Responsible for all daily RA processes and activities within the countries covered by the country operation as required.
- Provide strategic input and regulatory support 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.
- 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, ensuring 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 the Sales Department with Regulatory Documents (GMP certificates, Bioequivalence letters, and others) for Tender Bids.
- Support other regulatory processes as required by the Manager.
- Daily PV processes and activities within the country as required.
- Day-to-day adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
- Ensure that the vendor performs the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs).
- Ensure the ICSR acknowledgments and reconciliation activities for pharmacovigilance cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) are managed and ensure processes the reports in accordance to local procedures/pharmacovigilance legislations.
- Responsible for local preparation and submission to the Health Authority of the aggregate report in country.
- Support local pharmacovigilance 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.
- Support audits of contractual partners/vendors as necessary.
- Develop and maintain local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current.
- Supports required training of the local company staff, distributors, vendors, business partners, including training documentation (including maintenance of the local training matrix and onboarding plans).
- 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.
- May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally.
- Point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
- Liaise 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.
- Manage agency interface for safety and compliance issues.
- +2 years in Regulatory Affairs and Pharmacovigilance at Pharmaceutical Industry.
- Good knowledge of ICH, GMP, and local regulations.
- Language: Advanced/Native Spanish.
- Language: English (Reading, writing, and speaking) – advanced level.
- Proficient in MS Office software.
- Attention to detail.
- Ability to work cross-functionally in a pharmaceutical company environment.
- Time management.
- Good self-organization, creativity, and initiative.
- Flexible.
- Team-player.
- Accurate.
- Effective communication skills (both written and oral).
- Ability to transmit knowledge to others.
