SYNVIA

Pharmacovigilance Manager – CRO

SYNVIA

full-time

Posted on:

Location Type: Hybrid

Location: Brasil

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About the role

  • 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).
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data entryMedDRA codingWHO Drug codingcase processingadverse event triagesafety database managementquality control reviewsSOP developmentdata reconciliationpharmacovigilance training
Soft Skills
coordinationcommunicationorganizational skillsteam managementproblem-solvingattention to detailcollaborationleadershipprioritizationtraining