Remote Associate Director, Pharmacovigilance Scientist

Visa Hunt; United States; Hybrid; USD 184,000 - 200,000; Full time

Job summary

Candel is seeking an Associate Director, Pharmacovigilance Scientist to oversee safety evaluation across clinical development and post-marketing activities. The role involves collaboration with Clinical Development, Regulatory Affairs, and external partners to ensure high-quality safety assessments.

Responsibilities include SAE processing in Argus, safety topic reviews, and contributing to DSURs and regulatory responses while advancing signal management practices in a fast-paced biopharma

Qualifications

• Typically 8+ years of pharmacovigilance or clinical safety experience.
• Strong knowledge of global PV requirements (ICH GVP, FDA/EU safety rules).
• Experience with safety databases, especially Argus, and case processing workflows.

Responsibilities

• Sponsor review and approval of SAE reports in Argus with attention to completeness and causality.
• Author safety topic reviews, signal evaluations, and safety summaries for regulatory documents.
• Lead or support signal management processes and platform improvements.
• Review safety data from trials, databases, literature, and external sources for safety signals.
• Collaborate with Clinical Development and study teams on safety monitoring plans and study documents.

Skills

SAE review

Safety data review

Signal management

Regulatory submissions support

Documentation writing

Cross-functional collaboration

Education

PharmD

MSN/NP

MPH

Tools

Argus

Job description

Candel is seeking an Associate Director, Pharmacovigilance Scientist to oversee safety evaluation across clinical development and post-marketing activities. The role involves collaboration with Clinical Development, Regulatory Affairs, and external partners to ensure high-quality safety assessments.

Responsibilities include SAE processing in Argus, safety topic reviews, and contributing to DSURs and regulatory responses while advancing signal management practices in a fast-paced biopharma