Senior Director, Medical Safety and Safety Writing

VCLS; Paris; Sur place; EUR 80 000 - 120 000; Plein temps

Résumé du poste

An established industry player is looking for a Safety Physician to lead their Safety Surveillance and Medical Safety team. This pivotal role involves managing product benefit-risk profiles and overseeing safety data analysis. The ideal candidate will have extensive experience in pharmacovigilance and drug safety, guiding safety signal investigations, and ensuring compliance with global regulations. This role offers the opportunity to work collaboratively across functions, making a significant impact on patient safety in both pre- and post-marketing settings. If you're passionate about innovation and excellence in the life sciences, this position is perfect for you.

Qualifications

• Minimum 8 years of experience in pharmacovigilance or drug safety.
• Strong analytical skills to interpret complex clinical data.

Responsabilités

• Lead safety strategy for regulatory communication and oversee document preparation.
• Collaborate with cross-functional teams in clinical development and regulatory affairs.

Connaissances

Pharmacovigilance

Drug Safety

Clinical Development

Analytical Skills

Communication Skills

Formation

Medical Degree

Outils

Argus

Microsoft Office

Description du poste

Safety Physician - Safety Surveillance & Medical Safety

We are seeking an experienced physician to lead our Safety Surveillance and Medical Safety team as we continue to expand our Vigilance capabilities. This strategic role will manage product benefit-risk profiles, oversee safety data analysis, and guide safety signal investigations.

Key Responsibilities

1. Provide strategic patient safety input on drugs and medical devices in both pre- and post-marketing settings.
2. Lead safety strategy for regulatory communication and oversee the preparation of higher-level documents supporting submission activities.
3. Perform medical review and assessment of adverse event (AE) and serious adverse event (SAE) reports.
4. Write and review aggregate reports (e.g., PSUR, PBRER, DSUR, and ASR), Benefit-Risk Assessments, and Risk Management Plans.
5. Provide clinical expertise for safety signal detection, evaluation, and risk management.
6. Review and contribute to clinical study protocols, investigator brochures, and informed consent forms regarding safety content.
7. Contribute to safety sections of regulatory submissions and responses to health authorities.
8. Collaborate with cross-functional teams including clinical development, regulatory affairs, medical affairs, and vigilance operations.
9. Support the establishment and maintenance of pharmacovigilance systems and procedures in compliance with global regulations (e.g., FDA, EMA, ICH).
10. Provide medical guidance for safety data collection and analysis during clinical trials and post-marketing surveillance.
11. Assist in the preparation and presentation of safety data at internal and external meetings, including Safety Review Committees or Data Monitoring Committees.

This list is not exhaustive.

Requirements

1. Degree in medicine with experience as a physician in the Life Sciences space or as an academic clinician.
2. Minimum 8 years of experience in pharmacovigilance, drug safety, or clinical development within the pharmaceutical or biotechnology industry.
3. Knowledge of global pharmacovigilance regulations (FDA, EMA, ICH guidelines).
4. Strong analytical and critical thinking skills with the ability to interpret complex clinical data.
5. Excellent communication skills, both written and verbal (English).
6. Proficiency in safety databases (e.g., Argus) and Microsoft Office tools.
7. Alignment with our PIPE values: People, Innovation, Passion, and Excellence.