Patient Safety Manager

**Summary**:
LOCATION: Barcelona, Spain
ROLE TYPE: Hybrid working. #LI-Hybrid

The Patient Safety Manager is responsible for operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for the vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).

They also support the Country Patient Safety Head (CPSH) in the implementation of Patient Safety (PS) strategy at country level.

**About the Role**:
**Major accountabilities**:

- To be the accountable for specific operational vigilance process(es) at the Country Organization
- Ensure oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.
- Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates.
- Ensure local PS-related Risk Management Plan (RMP) commitments are executed and properly documented
- Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
- Provide scientific expertise during review of all Phase IV Clinical Trial and Non-Interventional Studies (NIS) protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
- Ensure timely preparation and submission of KPI reports on Adverse Event (AE) reporting or AE follow-up including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.
- Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.

**Key performance indicators**:

- Organisation, quality management and efficiency of vigilance processes
- Country Organization AE reporting compliance
- Internal and external customer satisfaction
- Compliance with RMP commitments

**Minimum Requirements**:
For this role we are searching for applicants with experience of case processing from Pharmacovigilance (PV) perspective at a local level.

They will also require the following:

- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
- Project management skills
- Excellent communications and negotiation (networking) skills
- Quality focused and results oriented
- 2 years’ experience in pharmacovigilance or equivalent field

**Languages**:
Fluency in both Spanish and English are essential for this position

**Why Novartis?**

**You’ll receive**:
**Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

**Join our Novartis Network**:
Division

Development

Business Unit

Innovative Medicines

Location

Spain

Site

Barcelona Gran Vía

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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