Hybrid Pharmacovigilance Manager – CRO

at SYNVIA

• Job title: Pharmacovigilance Manager – CRO
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Brasil

About the role

• Gerente de Farmacovigilância na Synvia, coordenando processos de segurança em estudos clínicos. Atuação em Campinas/ SP ou Paulínia/SP com trabalho remoto ocasional.

Responsibilities

• Coordinate and execute the processing of safety cases (SAEs, non-serious AEs, pregnancy exposure), including:
• Triage of adverse events received via email, eCRF, literature, investigational sites and other sources;
• Data entry into the sponsor's safety database;
• Preparation of narratives, follow-ups, queries and case closure;
• Perform or supervise MedDRA and WHO Drug coding of serious and non-serious adverse events in the eCRF;
• Ensure assessment of causality, severity and expectedness, liaising with investigators and medical reviewers;
• Prepare, review and update the Safety Plan and safety reports as needed;
• Submission and tracking of SUSARs to investigational sites and Ethics Committees (ECs);
• Periodic and final reconciliations between the eCRF and the safety database;
• Support preparation of ad hoc safety reports (e.g., DSUR, Dear Investigator letters, reports for Ethics Committees);
• Serve as the patient safety focal point with sponsors, investigational sites and internal departments;
• Develop, review and maintain SOPs, work instructions and quality controls;
• Perform and oversee quality control (QC) reviews, manage deviations and CAPAs;
• Conduct internal and external pharmacovigilance-related trainings;
• Participate in audits and regulatory inspections;
• Ensure compliance with ICH E2A, E2B, E6 (R2/R3), applicable ANVISA RDCs and sponsor contractual requirements;
• Coordinate workload distribution and prioritization of the Pharmacovigilance team activities.

Requirements

• Bachelor's degree in Pharmacy, Biomedicine or related field;
• Solid experience in pharmacovigilance applied to clinical trials;
• Experience in case processing, MedDRA, SUSARs and data reconciliation;
• Knowledge of ICH guidelines, ANVISA regulations and good patient safety practices;
• Experience in a CRO, sponsor or consultancy is a plus.

Benefits

• Commuting allowance (Transportation voucher);
• Parking (subject to availability);
• Health insurance with no monthly premium for the employee; copay applies for exams and consultations;
• Dental plan with employee copayment;
• Life insurance at no cost to the employee;
• Flexible meal/food allowance;
• Pharmacy benefit/discount program;
• Synvia Partner Club (education, language courses, leisure and culture benefits);
• SESC partnership;
• Physical wellness program – TotalPass;
• Day off – Health Professional;
• Childcare assistance (per internal policy).