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Jr Pharmacovigilance Analyst

Location São Paulo, Brazil

Jr Pharmacovigilance Analyst

Summary Description

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)

Responsabilities

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.

Education

Bachelor of Science in clinical science required (ie. Nursing, Pharmacy, Medicine, Biomedicine, etc).

Experience

06months to 01-year Pharmacovigilance experience preferred.

Fluency in English and good knowledge of Spanish

BioMarin 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.

About our location

São Paulo

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