**299651BR**
**Job ID:**
299651BR
**Job Description:**
To support management of processes in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
Your responsibilities include, but are not limited to:
•Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.
•Participates in the resolution of any legal liability and aligning with government regulations.
•Ensures accurate receipt, maintenance and assessment against product labeling.
•Reports events or reactions as the need arises by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports.
•May provide trending and safety signal detection and assessment.
•Supports all clinical trial activity and post marketing.
You’ll receive:
Competitive salary, annual bonus, health insurance, flexible working arrangements, employee recognition scheme.
Why consider Novartis?
799 million. That’s how many lives our products touch in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
**Position Title:**
Patient Safety Specialist
**Minimum requirements:**
*Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
*Fluent in both written and spoken English
*Fluent in both written and spoken local language
*Knowledge of national and international regulations for pharmacovigilance
*Knowledge of pharmacological and medical terminology.
*Excellent communications, interpersonal and negotiation skills
*Quality and focus oriented
*Computer skills
**Job Type:**
Full Time
**Country:**
Guatemala
**Work Location:**
Guatemala
**Functional Area:**
Research & Development
**Division:**
Global Drug Development
**Business Unit:**
CMO & PATIENT SAFETY GDD
**Employment Type:**
Regular
**Company/Legal Entity:**
NOV PHA Logistics PAN
**Shift Work:**
No
