Executive Safety Leader, Pharmacovigilance & Product Safety

Pretzeltx; Boston (MA); Hybride; USD 250 000 - 350 000; Plein temps

Avantages offerts par ce poste

Competitive compensation package

Bonus eligibility

Stock options

Health, dental, and vision coverage

Résumé du poste

The Sr. Director, Pharmacovigilance / Product Safety (MD) at Pretzel Therapeutics in Boston leads safety strategy across the clinical portfolio, ensuring rigorous risk assessment and FDA-compliant practices.

You will oversee safety surveillance, aggregate reports, and governance, partner with Regulatory Affairs and Clinical Development, and counsel senior leadership on benefit-risk decisions.

Hybrid work in Boston combines strategic leadership with hands-on oversight in a lean biotech environment.

Qualifications

• MD required.
• Extensive pharmacovigilance/drug safety background with clinical development exposure.
• Strong knowledge of FDA/ICH regulations and safety reporting.

Responsabilités

• Provide strategic and medical leadership for pharmacovigilance and product safety across Pretzel’s portfolio.
• Lead safety surveillance strategies and risk management throughout clinical development.
• Oversee aggregate safety reports, DSURs, and ongoing benefit-risk evaluation.
• Partner with Regulatory Affairs and Clinical Development to ensure compliance and regulatory submissions.
• Guide governance, external vendors, and safety-related program decisions.

Connaissances

Leadership

Strategic thinking

Regulatory knowledge

Cross-functional collaboration

Communication

Formation

MD

Outils

Pharmacovigilance systems

Description du poste

The Sr. Director, Pharmacovigilance / Product Safety (MD) at Pretzel Therapeutics in Boston leads safety strategy across the clinical portfolio, ensuring rigorous risk assessment and FDA-compliant practices.

You will oversee safety surveillance, aggregate reports, and governance, partner with Regulatory Affairs and Clinical Development, and counsel senior leadership on benefit-risk decisions.

Hybrid work in Boston combines strategic leadership with hands-on oversight in a lean biotech environment.