Medical Safety Lead

More than 52 different medical diseases Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative medicines.
- As Medical Safety Lead, you will be part of a team that gets important compounds to market safely, helping millions of patients.**Your responsibilities will include but are not limited to**:

- Monitoring the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and respond to safety related questions effectively.
- Perform medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees.
- Identify safety signals based on the review of solicited or unsolicited single cases. Performing signal detection, monitoring and evaluation of all safety signals.
- Contributing towards responses to inquiries from regulatory authorities or health care professionals on safety issues.
- Preparing safety data for Health Authority review boards. Providing inputs to responses for legal queries and Country Organization requests involving safety issues.
- Providing expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
- Collaborate productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
- Contribute to the development of departmental goals and objectives.

**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**

**What you’ll bring to the role**:

- Health/Science University Degree
- Proficiency English (oral and written)
- Ability to work and lead (a cross-functional team) in a matrix environment
- 3-5 years working experience within the pharmaceutical industry
- Experience Medical Safety Analysis and synthesis of safety data

Experience in the follow areas are an advantage: Benefit/Risk Evaluation, Epidemiology Post Authorization, and Data Safety.**You’ll receive**: Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours.**Why consider Novartis?**

769 million. That’s how many lives our products touch. 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.**Imagine what you could do at Novartis**

**Division**
- Global Drug Development

**Business Unit**
- CMO & PATIENT SAFETY GDD

**Country**
- Spain

**Work Location**
- Barcelona

**Company/Legal Entity**
- Novartis Farmacéutica, S.A.

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No