Director/Senior Director Global Program Safety Physican (US/EU/IL)

Prilenia; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

An innovative clinical-stage biotechnology company is seeking a Director/Senior Director Global Program Safety Physician. This pivotal role involves developing safety strategies in compliance with global regulations, focusing on drug safety and pharmacovigilance. The ideal candidate will have extensive experience in the field, particularly in rare diseases and neurology. Join a flexible and fast-moving team dedicated to making a significant impact on patients' lives through novel therapeutics. This remote position offers the opportunity to work across multiple regions and contribute to groundbreaking therapies.

Qualifications

• 7+ years in Drug Safety & Pharmacovigilance, including clinical and post-marketing phases.
• Experience in rare diseases and neurology preferred.

Responsibilities

• Provide safety input to drug development and compile safety data for regulatory documents.
• Lead safety reports ensuring regulatory compliance and chair Safety Management Teams.

Skills

Clinical Judgment

Data Interpretation

Communication Skills

Cross-functional Teamwork

Pharmacovigilance Regulations Knowledge

Education

Medical Degree

Job description

Director/Senior Director Global Program Safety Physician (US/EU/IL)

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About Prilenia
Prilenia Therapeutics is a clinical-stage biotechnology company dedicated to developing novel therapeutics for neurodegenerative diseases and neurodevelopmental disorders. We are seeking a Global Program Safety Physician to join our team in the US, Europe, or Israel.

Prilenia is a flexible, fast-moving team advancing a potential therapy that could significantly impact patients' lives. Our lead candidate, pridopidine, has Orphan Drug Designation in Huntington’s disease (HD) and ALS in the US and EU, and Fast Track designation from the FDA for HD. We are also in discussions with regulatory authorities for broader approvals and preparing for a Phase 3 trial in ALS.

Our offices are located in the US, Israel, and The Netherlands. We operate remotely and encourage flexible work arrangements to maximize effectiveness.

Learn more about us at https://Prilenia.com.

About The Role

We seek a highly qualified professional for the role of Director/Senior Director, Global Program Safety Physician (GPSP). The role involves developing and executing safety strategies in compliance with global regulations, with profound experience in Drug Safety & Pharmacovigilance and Risk Management.

Roles And Responsibilities

• Provide safety input to drug development and post-marketing programs.
• Compile safety data for clinical overviews, safety assessments, risk management plans, and regulatory documents.
• Evaluate safety information collaboratively with external vendors.
• Lead and review safety reports (e.g., DSUR, PBRER/PSUR) ensuring regulatory compliance.
• Maintain core safety information for product labeling and documentation.
• Lead signal detection and safety surveillance activities.
• Support risk management strategies for investigational drugs.
• Address safety questions from Regulatory Authorities.
• Chair multidisciplinary Safety Management Teams.
• Support safety data trending and regulatory communication strategies.
• Assist in PV audits and inspections, ensuring readiness.

Qualifications

• Medical degree with clinical experience.
• At least 7 years of experience in Drug Safety & Pharmacovigilance, including clinical and post-marketing phases.
• Experience in rare diseases and neurology preferred.
• Expertise in signal detection, safety data analysis, and reporting.
• Knowledge of global regulatory requirements.

Skills

• Strong clinical judgment and data interpretation skills.
• Excellent communication skills.
• Ability to work effectively in cross-functional teams and independently.
• Knowledge of international pharmacovigilance regulations.

Location/Time Zones

• Remote position with occasional in-person meetings.
• Flexible scheduling across Israel, North America, and Europe.
• Occasional international travel required.

Senior Level

Director

Employment Type

Full-time