Senior Director, Safety Scientist

Remotedxb; Dubai; On-site; AED 600,000 - 1,000,000; Full time

Job summary

Parabilis Medicines is seeking a seasoned Safety Scientist to lead pharmacovigilance across development programs in a fast-moving biotech environment. You will author SSPs, SARs, DSURs, and other safety documents, perform signal detection, and partner with global health authorities to ensure risk-based decision making throughout clinical development.

The role requires advanced life sciences degree and 12+ years in drug safety, with proficiency in MedDRA, safety databases, and data visualization

Qualifications

• Advanced degree in life sciences, pharmacy, nursing, or medicine.
• 12+ years of pharmacovigilance or drug safety experience.
• Expertise in safety surveillance, signal detection, and benefit-risk assessment.
• Experience authoring SSPs, SARs, dRMPs, DCSI, IBs, and DSURs.
• Experience supporting regulatory interactions with FDA, EMA, ICH.
• Proficiency with safety databases, MedDRA coding, SMQs, and Spotfire.
• Ability to lead complex cross-functional initiatives.
• Proficiency with AI tools for day-to-day tasks.

Responsibilities

• Lead safety science activities for assigned development programs and provide strategic input into benefit-risk assessment.
• Author and maintain Safety Surveillance Plans (SSPs), Development Risk Management Plans (dRMPs), and Development Core Safety Information (DCSI).
• Perform signal detection and management activities, including maintenance of the signal tracker.
• Contribute to literature surveillance to identify and evaluate potential safety signals.
• Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest.
• Partner with internal stakeholders to leverage visualization tools like Spotfire for safety analysis.
• Author Signal Analysis Reports (SARs) and support risk characterization and mitigation strategies.
• Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings.
• Develop scientific materials for safety-focused advisory boards and Key Opinion Leader (KOL) meetings.
• Contribute safety expertise to Investigator's Brochures, clinical protocols, informed consent forms, and DSURs.
• Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications (CTAs).

Skills

Pharmacovigilance

Safety surveillance

Signal detection

Regulatory interactions

Spotfire

MedDRA

AI tools

Cross-functional leadership

Education

PharmD/PhD/MD

Tools

Safety databases

MedDRA coding

Spotfire

AI tools

Job description

About the Company

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines.

Responsibilities

• Lead safety science activities for assigned development programs and provide strategic input into benefit-risk assessment
• Author and maintain Safety Surveillance Plans (SSPs), Development Risk Management Plans (dRMPs), and Development Core Safety Information (DCSI)
• Perform signal detection and management activities, including maintenance of the signal tracker
• Contribute to literature surveillance to identify and evaluate potential safety signals
• Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest
• Partner with internal stakeholders to leverage visualization tools like Spotfire for safety analysis
• Author Signal Analysis Reports (SARs) and support risk characterization and mitigation strategies
• Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings
• Develop scientific materials for safety-focused advisory boards and Key Opinion Leader (KOL) meetings
• Contribute safety expertise to Investigator's Brochures, clinical protocols, informed consent forms, and DSURs
• Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications (CTAs)

Requirements

• Advanced degree in Life Sciences, Pharmacy, Nursing, or Medicine (PharmD, Ph.D., or MD)
• 12+ years of experience in pharmacovigilance, drug safety, or safety science in biotech or pharma
• Expertise in safety surveillance, signal detection, and benefit-risk assessment across clinical phases
• Experience authoring SSPs, SARs, dRMPs, DCSI, IBs, and DSURs
• Experience supporting regulatory interactions with global health authorities (FDA, EMA, ICH)
• Proficiency with safety databases, MedDRA coding, SMQs, and data visualization tools like Spotfire
• Ability to lead complex cross-functional initiatives in a matrixed organization
• Proficiency with AI tools for day-to-day work tasks

Preferred Qualifications

• Prior experience in oncology, rare disease, or immunology