Medical Safety Lead

Medical Safety Lead

Location: Barcelona (hybrid) or United Kingdom (remote)

Our Medical Safety Lead within the Cardio Renal Metabolic (CRM) therapeutic area is part of a team that gets important compounds to market safely, helping millions of patients with serious diseases! This role will report to the Head Patient Safety CRM.

Key Responsibilities

1. Monitoring the clinical safety of projects/products including activities such as literature review, evaluation of individual cases or signal detection, and responding to safety-related questions effectively.
2. 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.
3. Identify safety signals based on the review of solicited or unsolicited single cases. Performing signal detection, monitoring and evaluation of all safety signals.
4. Contributing towards responses to inquiries from regulatory authorities or health care professionals on safety issues.
5. Preparing safety data for Health Authority review boards. Providing inputs to responses for legal queries and Country Organization requests involving safety issues.
6. Providing expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
7. Collaborate efficiently on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
8. Contribute to the development of departmental goals and objectives.

Commitment to Diversity & Inclusion

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

Role Requirements

Essential Requirements

1. Medical Degree (preferred) but PhD, PharmD also considered.
2. Proficient English (oral and written).
3. Sufficient experience in drug development in a major pharmaceutical company, including some years of experience in patient safety ideally in an operational or medical position.
4. Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
5. Proven ability to analyse, interpret, discuss, and present safety information both in writing and orally.
6. Experience in preparing or contributing to the preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
7. Experience with (safety or other) issue management.

Experience in the following areas would be an advantage

1. Understanding in another major language (e.g. French, German, Spanish).

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Division: Global Drug Development

Business Unit: Patient Safety & Pharmacovigilance

Work Location: Barcelona Gran Vía

Company/Legal Entity: Novartis Farmacéutica, S.A.

Alternative Country 1: United Kingdom

Functional Area: Research & Development

Job Type: Full Time

Employment Type: Regular

Shift Work: No

Early Talent: No