Patient Safety Specialist

hace 2 días

Lima, Perú Novartis A tiempo completo

To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group, marketed and investigational products (drugs and devices).

Your responsibilities include, but are not limited to:

- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Orient-ed Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
- Adverse Events will be reported within 24 hours of the associate learning of the event.
- Handle reporting/submission/distribution of safety reports/updates/information to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
- Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Input, review and approval of program proposals for language, content and establishment of vital controls on collection and reporting of adverse event information.

**Commitment to Diversity & Inclusion**:

- 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
- 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

You’ll receive:
Competitive salary, annual bonus, flexible working arrangements, subsidized dining facilities, employee recognition scheme, professional development, learning experiences, diversity & inclusion.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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

**Division**

Global Drug Development

**Business Unit**

CMO & PATIENT SAFETY GDD

**Country**

Peru

**Work Location**

Lima

**Company/Legal Entity**

NOV BIOSC PER

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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