349246BR
Jul 19, 2022
Argentina

Job Description

21,000. That’s how many people Novartis hires globally every year. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?

The people we serve need you to achieve the extraordinary. That's why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.

This role 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 in complying with government regulations.

Your responsibilities include, but are not limited to:
-To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
-Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
-Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
-Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments
-Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
-Work with other local/global PV associates to ensure accurate evaluation of safety data.
-Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
-Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
• English/Spanish
• Knowledge of national and international regulations for pharmacovigilance
• Previous experience in similar roles
• Knowledge of pharmacological and medical terminology
• Excellent communications, interpersonal and negotiation skills
• Quality and focus oriented
• Computer skills

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
Argentina
Buenos Aires
Research & Development
Part Time
75
Regular
No
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349246BR

Patient Safety Specialist

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