Senior PV Scientist & Safety Lead – Associate Director

Scorpion Therapeutics; Needham (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Pharmacovigilance Scientist to lead safety evaluation across clinical development and post-marketing readiness. You will partner cross-functionally to detect, assess, document, and prevent product safety risks, with a focus on oncology/gene-therapy programs.

Responsibilities include SAE review, safety analyses, signal management, regulatory documentation, and collaboration with PV vendors.

Qualifications

• Advanced degree in health/life sciences preferred.
• 8+ years in pharmacovigilance/clinical safety with oncology or gene therapy emphasis.
• Experience with safety data management, regulatory submissions, and safety monitoring plans.

Responsibilities

• Review SAE reports for completeness, coding, and narrative quality.
• Author safety analyses and contribute to governance documents (DSURs, ICRs, clinical reports).
• Lead signal management activities including detection, validation, and escalation.
• Review safety data from trials, databases, literature, and nonclinical sources.
• Collaborate with PV vendors/CROs for case processing and documentation.

Skills

Pharmacovigilance

GCP/ICH

Causality assessment

Signal detection

Regulatory documentation

Communication

Project coordination

Safety database Argus

Medical writing

Education

Advanced degree in health/life sciences

PharmD/MPH or related

Tools

Argus

Job description

Scorpion Therapeutics seeks an Associate Director, Pharmacovigilance Scientist to lead safety evaluation across clinical development and post-marketing readiness. You will partner cross-functionally to detect, assess, document, and prevent product safety risks, with a focus on oncology/gene-therapy programs.

Responsibilities include SAE review, safety analyses, signal management, regulatory documentation, and collaboration with PV vendors.