Jr Pharmacovigilance AnalystLocation São Paulo, Brazil Apply
Jr Pharmacovigilance Analyst
This position will support the Sr Pharmacovigilance Manager mainly in operational processing of Adverse Events (AEs).
Identifies ICSRs requiring expedited reporting to Competent Authorities according to local requirements.
Escalation of any issues that may impact on quality or compliance to the Pharmacovigilance Sr. Manager.
Maintain an accurate and organized record of electronic and physical files in BPV BR.
Support Sr. PV Manager in trainings to other staff – new hires, recycle, PSP, SAC (Customer Service) -, as well as external HCPs Pharmacovigilance training (when applicable)
Assist with the collection, reporting and follow-up of safety information – adverse event (AE) or Special Situation Events (SSE) reports
Daily check of Pharmacovigilance inbox forwarding AE reports to BPV
Forward to BPV all new AE and/or SSE and follow up information received
Review of presentations from speakers
Perform follow up attempts for all Latin America cases
Translate or ask translation for the applicable cases before submission and perform quality check of the translation (if translation done by a vendor or other person) before submissions to Regulatory Agencies
Case submission to local Regulatory Agencies (as required)
Maintain local tracker updated
Organize/file electronic and physically
Perform monthly reconciliation with BPV
Perform monthly reconciliation with Brazil PSPs
Assist with training to the new hires (staff or 3rd partners), recycle training and any other as applicable
Assist with local SOP development and review
Participation in internal and external audits and inspections by HA
Participation on relevant meetings as recommended by PV Mng
Be the Deputy Pharmacovigilance Responsible Person in Brazil (deputy RP PV BR) in collaboration with RP PV BR. Other duties as assigned.
Bachelor of Science in clinical science required (ie. Nursing, Pharmacy, Medicine, Biomedicine, etc).
06months to 01-year Pharmacovigilance experience preferred.
Fluency in English and good knowledge of SpanishBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.