Drug Safety Specialist (Xico)

Drug Safety Specialist (Xico)

02 ago
|
Precision For Medicine
|
Xico

02 ago

Precision For Medicine

Xico

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!

Main Duties & Responsibilities

Process IC&S; according to SOPs and project‑specific safety plans

Triages IC&S;, evaluates data for completeness and regulatory reportability

Enter data into Argus Safety Database

Code events, medical history, concomitant meds, and tests

Draft case narratives

Query resolution and follow‑up until complete

Generate timely expedited regulatory reports

Coordinate reconciliation of safety and clinical databases

Ensure required safety reports distribution

Participate in audits/inspections

Submit documents to TMF/PV System MF

Maintain compliance with SOPs, GCP, ICH, GVP, regulations

Attend department meetings

Participate in project meetings

Other duties as assigned

Education And Experience
Minimum Education & Experience:

Minimum 2 years clinical trial drug safety experience; Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent. Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulations





Professional working proficiency in English

Preferred Education & Experience

Early phase oncology experience preferred

Knowledge, Skills, And Competencies

Strong knowledge of safety reporting requirements and guidelines

Ability to analyze and evaluate clinical safety data

Strong written communication and narrative writing skills

Experience with Argus, MedDRA, WHODrug

Strong attention to detail

Ability to manage multiple cases and deadlines

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

#J-18808-Ljbffr

📌 Drug Safety Specialist (Xico)
🏢 Precision For Medicine
📍 Xico

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: drug safety specialist (xico) / xico

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: drug safety specialist (xico) / xico