Senior Pharmacovigilance Scientist & PV Lead (Remote)

Candel Therapeutics, Inc.; Needham (MA); Hybrid; USD 184,000 - 200,000; Full time

Job summary

Candel Therapeutics, Inc. is seeking an Associate Director, Pharmacovigilance Scientist to advance safety evaluation across clinical development and post-marketing readiness. You will oversee SAE reviews, support signal management, and collaborate with cross-functional teams.

The role requires extensive PV experience, strong regulatory knowledge, and ability to produce safety documents. This remote/hybrid position offers a competitive salary in Needham, MA area.

Qualifications

• Advanced degree in health sciences or life sciences with pharmacovigilance focus.
• 8+ years in pharmacovigilance or clinical safety in biotech/pharma/CRO settings.
• Experience with safety databases, case processing, and regulatory reporting.
• Ability to contribute to protocols, DSURs, and safety documents.

Responsibilities

• Perform SAE and case safety report reviews in Argus with high accuracy.
• Author safety topic reviews and safety summaries for regulatory documents.
• Support signal management process and aggregate safety analyses.
• Review safety data from trials, literature, and databases for safety signals.
• Collaborate with study teams on safety monitoring plans.
• Ensure regulatory readiness and inspection support for PV activities.

Skills

Pharmacovigilance

Regulatory knowledge

Cross-functional collaboration

Medical writing

Education

PharmD, MPH, MSN/NP or related field

Bachelor's degree with significant pharmacovigilance experience

Tools

Argus Safety

Job description

Candel Therapeutics, Inc. is seeking an Associate Director, Pharmacovigilance Scientist to advance safety evaluation across clinical development and post-marketing readiness. You will oversee SAE reviews, support signal management, and collaborate with cross-functional teams.

The role requires extensive PV experience, strong regulatory knowledge, and ability to produce safety documents. This remote/hybrid position offers a competitive salary in Needham, MA area.