Local Safety Officer 145

hace 3 semanas

Mexico City ProductLife Group A tiempo completo

PLG is currently seeking a highly motivated individual for the position of Local Safety Officer in Mexico. As a vital member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry. Join us in our mission to uphold the highest standards of safety and quality in pharmaceutical products.

Group 10 Responsibilities

Serve as the Local Safety Officer for PLG clients in LATAM Liaise with local regulatory authorities, staying updated on local regulations and requirements Establish and maintain the Local Pharmaceutical Safety Management Framework (PSMF) Assist in the development and upkeep of local Standard Operating Procedures (SOPs) and agreements, including the Safety Data Exchange Agreement (SDEA), Pharmacovigilance Agreement (PVA), and Technical Agreement (TA) Support local Pharmacovigilance (PV) and Medical Information (MI) activities Collaborate with clients, affiliate departments, and third-party vendors Ensure compliance with client and PLG policies and procedures to meet statutory, quality, and business requirements

Safety Information and Medical Information Management:

Handle the receipt, processing, translation, and quality control (QC) tracking of safety information for PLG clients in LATAM Submit Local Individual Case Safety Reports (ICSRs) to regulatory authorities as per local legislation Conduct periodic reconciliations to ensure proper management of vigilance reports for PLG clients Provide or assist in local medical information services

Local Literature and Regulatory Website Monitoring:

Monitor local literature and journals for products of PLG’s clients in LATAM Conduct QC and track results from literature monitoring activities Assist in selecting and reviewing the local journal list as needed Monitor Colombian/LATAM authority websites for changes in national legislation or safety information relevant to PLG clients Track regulatory authority screenings and communicate results to relevant PLG clients

Group 12 Experience

Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a related scientific field, or equivalent experience 2+ years of pharmacovigilance experience Strong understanding of both local and international regulations Essential experience in local pharmacovigilance case management, including receipt, translation, submission, and follow-up Desirable experience as a local contact person in LATAM Desirable experience in screening local literature and regulatory websites Desirable previous experience conducting pharmacovigilance activities in LATAM for a European company Proficiency in MS Word and MS Excel Desirable experience with safety databases, particularly MedDRA Desirable experience in conducting local medical information activities Excellent fluency in English and Spanish Strong organizational and interpersonal skills Ability to collaborate effectively within a team Demonstrated accountability and autonomy in handling assigned tasks

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