Clinical Research Doctor

SRG; Madrid; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading clinical development organization in Madrid is seeking an experienced Safety Physician to provide safety oversight across ongoing and upcoming clinical development projects. The role requires significant expertise in Clinical Safety and Pharmacovigilance and involves both operational and strategic contributions. The ideal candidate will have an MBBS or MD, with a minimum of 7 years of Drug Safety experience in clinical trials. This position plays a critical role in shaping safety strategy across the clinical development lifecycle.

Formación

• Minimum 7 years of experience in Drug Safety within clinical trials.
• Strong expertise in pharmacovigilance activities.

Responsabilidades

• Provide comprehensive safety oversight for clinical development programs.
• Author and review pharmacovigilance documents.
• Develop and maintain risk management plans.
• Conduct signal detection and ongoing risk management.
• Prepare and review critical safety documents.

Conocimientos

Clinical Safety

Pharmacovigilance

Risk Management

Signal Detection

Safety Oversight

Educación

MBBS or MD

Descripción del empleo

We are currently looking for an experienced Safety Physician to support ongoing and upcoming clinical development projects. This role requires a highly competent professional with strong expertise across Clinical Safety and Pharmacovigilance, contributing both operationally and strategically.

Key Responsibilities

• Providing comprehensive safety oversight across early- and late-stage development programs
• Authoring and reviewing the pharmacovigilance sections of Investigator’s Brochures
• Developing and maintaining risk management plans and associated safety documentation
• Conducting signal detection, evaluation, and ongoing risk management activities
• Supporting responses to questions and requests from global health authorities
• Preparing, reviewing, and contributing to key clinical and safety documents, including CSRs, ICFs, CSPs, IBs, and DSURs
• Performing narrative reviews, evaluation of SAEs and AESIs, database reconciliation, and related safety activities
• Defining and driving safety strategy for early clinical development programs
• Collaborating closely with cross-functional clinical trial teams on critical safety topics
• Providing strategic input into pharmacovigilance activities and coordinating with both internal teams and external partners

Mandatory Requirements

• Must have MBBS or MD as an educational background.
• Must have 7 years of Drug Safety experience, that in the clinical trial environment.

This role offers the opportunity to play a critical part in shaping and executing safety strategy across the clinical development lifecycle.