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Ra & Pv Specialist\\ Cenca Region
hace 1 mes
Job DescriptionDescription 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.
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) ensuring that they are kept current.
Manage agency interface for safety and compliance issues.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 post-marketing surveillance 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.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.Required Education, Experience and Skills +2 years in Regulatory Affairs at Pharmaceutical IndustryGood knowledge of ICH, GMP and local regulations.Pharmacist or related sciencesCentral America & Caribbean countries legal regulationsRegulatory and post-marketing surveillance activitiesLeadership behaviorsSpanishEnglish (Reading, writing and speaking) -advanced levelProficient in MS Office softwareAttention to detailAbility to work cross-functionally in pharmaceutical
