Associate Director, Pharmacovigilance Scientist
Candel Therapeutics
August 26, 2026
Remote friendly (Needham, MA)
United States
Operations
Position Summary:
The Associate Director, Pharmacovigilance Scientist supports safety evaluation and pharmacovigilance activities for all products across clinical development and, as applicable, post-marketing readiness. Partners cross-functionally to detect, assess, understand, document, and prevent product safety risks.
Essential Responsibilities:
- Perform sponsor review and approval of serious adverse event (SAE) and other individual case safety reports in Argus (completeness, medical consistency, queries, coding, narrative quality, causality, expectedness, reportability, and follow-up).
- Author/contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-risk assessments, and safety summaries for governance and regulatory documents (e.g., Investigator Brochure updates, DSURs, clinical study reports).
- Implement and continuously improve signal management (detection, tracking, validation, prioritization, assessment, escalation, documentation, inspection-ready records).
- Review safety data from trials, safety/clinical databases, literature, and nonclinical sources to identify emerging concerns and changes in known risks.
- Support protocol development/amendments, safety monitoring plans, and safety sections of study documents.
- Contribute to SAE reconciliation, safety data meetings, Safety Management/Governance Team activities, and Data Monitoring Committee support.
- Maintain Reference Safety Information, expectedness criteria, terms of special interest, and product risk language.
- Collaborate with PV vendors/CROs for quality case processing, query resolution, safety database documentation, compliance, and oversight of delegated PV activities.
- Provide PV input to regulatory responses, inspections readiness, SOPs/work instructions, vendor oversight plans, training, and process improvements.
- Maintain knowledge of global PV regulations, ICH guidance, FDA/EU expectations, oncology safety considerations, MedDRA, and best practices.
Minimum Education:
- Advanced degree in a health/life sciences discipline preferred (e.g., PharmD, MSN/NP, MPH). Bachelor’s may be considered with significant relevant experience.
Experience & Qualifications:
- Typically 8+ years in pharmacovigilance/clinical safety/drug safety science/clinical development (oncology and/or gene-mediated therapy preferred).
- Strong knowledge of global PV requirements (ICH GCP, ICH E2, FDA IND safety reporting, EU clinical trial safety reporting, Good Pharmacovigilance Practice).
- Hands-on safety database experience, preferably Argus.
- Ability to review complex safety/clinical data and produce clear written safety assessments.
- Experience supporting protocol/investigator brochure/DSURs/clinical reports/safety monitoring plans/signal assessments and regulatory responses.
- Knowledge of signal detection/management practices.
- Excellent written/verbal communication; strong organizational skills; collaborative, proactive, accountable style.
Application Instructions:
- All applicants must be authorized to work in the US and do not require sponsorship; sponsorship is not available.
The Associate Director, Pharmacovigilance Scientist supports safety evaluation and pharmacovigilance activities for all products across clinical development and, as applicable, post-marketing readiness. Partners cross-functionally to detect, assess, understand, document, and prevent product safety risks.
Essential Responsibilities:
- Perform sponsor review and approval of serious adverse event (SAE) and other individual case safety reports in Argus (completeness, medical consistency, queries, coding, narrative quality, causality, expectedness, reportability, and follow-up).
- Author/contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-risk assessments, and safety summaries for governance and regulatory documents (e.g., Investigator Brochure updates, DSURs, clinical study reports).
- Implement and continuously improve signal management (detection, tracking, validation, prioritization, assessment, escalation, documentation, inspection-ready records).
- Review safety data from trials, safety/clinical databases, literature, and nonclinical sources to identify emerging concerns and changes in known risks.
- Support protocol development/amendments, safety monitoring plans, and safety sections of study documents.
- Contribute to SAE reconciliation, safety data meetings, Safety Management/Governance Team activities, and Data Monitoring Committee support.
- Maintain Reference Safety Information, expectedness criteria, terms of special interest, and product risk language.
- Collaborate with PV vendors/CROs for quality case processing, query resolution, safety database documentation, compliance, and oversight of delegated PV activities.
- Provide PV input to regulatory responses, inspections readiness, SOPs/work instructions, vendor oversight plans, training, and process improvements.
- Maintain knowledge of global PV regulations, ICH guidance, FDA/EU expectations, oncology safety considerations, MedDRA, and best practices.
Minimum Education:
- Advanced degree in a health/life sciences discipline preferred (e.g., PharmD, MSN/NP, MPH). Bachelor’s may be considered with significant relevant experience.
Experience & Qualifications:
- Typically 8+ years in pharmacovigilance/clinical safety/drug safety science/clinical development (oncology and/or gene-mediated therapy preferred).
- Strong knowledge of global PV requirements (ICH GCP, ICH E2, FDA IND safety reporting, EU clinical trial safety reporting, Good Pharmacovigilance Practice).
- Hands-on safety database experience, preferably Argus.
- Ability to review complex safety/clinical data and produce clear written safety assessments.
- Experience supporting protocol/investigator brochure/DSURs/clinical reports/safety monitoring plans/signal assessments and regulatory responses.
- Knowledge of signal detection/management practices.
- Excellent written/verbal communication; strong organizational skills; collaborative, proactive, accountable style.
Application Instructions:
- All applicants must be authorized to work in the US and do not require sponsorship; sponsorship is not available.