Pharmacovigilance Supervisor - CDMX
- Ciudad de México Sudamérica
- Permanente
- Tiempo completo
▪ Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance. Accountable internally for ensuring that the LOC meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
▪ Oversight responsibilities of case processing operational activities delegated to the Center of Excellence Case Processing hub for Latin America or external vendor as appropriate. Case processing activities include but not limited to Inbound reporting, outbound reporting, translation of AEs/Special Reporting Situations/PQCs, literature search, due diligence.
▪ Accountable for compliance monitoring for submissions to Competent Authorities (HAs). Reconcile compliance data provided and take appropriate corrective actions as defined by company policies and procedures.
▪ Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Inform the appropriate global and regional groups (i.e. QPPV office and regional heads) of any changes to local laws and regulations regarding Pharmacovigilance
▪ Oversight of timely elaboration and submission of all documents required by local PV legislation.PV SYSTEMS COMPLIANCE
▪ Oversight of timely and appropriate communication & follow up of the activities related with Global Clinical Operations (GCO & GCO MAO) to comply with PV local regulations regarding clinical trials conducted in the territory as applicable, including those carried out by third parties, as per the contracts & agreements.
▪ Oversight of timely and appropriate Development of Local Implementation Memos (LIM) for Regional / PV Standard Operating Procedures/Working Practices and verify adherence.
▪ Managing and scheduling of the preparation of necessary outlines, status reports, graphs, charts, tables, and slides for periodic reviews for the Pharmacovigilance specialists.
▪ Monitor data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research studies, marketing activities, internet sites, surveys, etc.), as applicable.
▪ Oversight of timely and appropriate of the performance of periodic revisions of Research Related Activities (RRAs), delegated to the Regional PV Hub for Latin America or external vendor asappropriate.
▪ Review and adequate guidance for the selection and inclusion of pharmacovigilance clauses for the preparation of service and technical contracts and drafting of pharmacovigilance agreements with business partners for commercial agreements.AUDIT / INSPECTION PREPARATION AND SUPPORT
▪ Reception and leadership of any inspections and audits inspectors / auditors and support document requests in case of internal/external audits. Support and oversight of self- identified CAPAs for PV system non-conformances identified in the territory of responsibility. Support and oversight for the follow-up actions from finding and monitor non- LSO safety- related corrective actionsOTHER ACTIVITIES
▪ Management and support of local Pharmacovigilance staff (if appropriate).
Close connection with LOC departments including but not limited to Medical Affairs, Commercial Quality, Business Intelligence, Marketing and Sales, participating in projects, meetings and business reviews/issue management teams as required, providing strategical input
Components of the LSO role may be delegated to the PV Specialist, as back-up of the Local Safety Officer (LSO), with appropriate training/documentation ensuring that the overall requirements are met and when no other position in the LSU is availableREQUIREMENTS:▪ A degree in life or pharmaceutical, health sciences or Medical degree is preferable.
Essential knowledge & skills
▪ Knowledge and understanding of key legislation applicable to pharmacovigilance within Mexico and Good Pharmacovigilance Practices.
▪ Verifiable knowledge in Sanitary Regulation (extensions, modifications, requests for new Sanitary registries).
▪ Verifiable knowledge of Pharmacovigilance in clinical studies.
▪ Familiarity with global ICSR related global, regional and local PV procedural documents asapplicable.
▪ Ability to prioritize and work to strict timelines daily
▪ Excellent verbal and written communication skills
▪ Fluency in English language is required
▪ Ability to negotiate and communicate with internal and external customers
Experience
▪ Proven expertise and experience in Pharmacovigilance regulations and Sanitary Regulation processes is desirable.
▪ By preference a minimum of 3 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role