Associate Director, Pharmacovigilance Scientist

Candel Therapeutics•Needham, MA

1d•$184,000 - $200,000•Hybrid

About The Position

The Associate Director, Pharmacovigilance Scientist will support the ongoing safety evaluation and pharmacovigilance activities for all Candel products across clinical development and, as applicable, post-marketing readiness. Reporting to the Senior Director, Pharmacovigilance and Safety, this individual will contribute to the detection, assessment, understanding, documentation, and prevention of product safety risks by partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Writing, Quality, external vendors, and study teams. The role will include sponsor review and approval of serious adverse event cases in Argus, authoring safety topic reviews, supporting protocol and safety document development, and helping implement a robust signal management process and platform.

Requirements

Advanced degree in a health sciences or life sciences discipline preferred, such as PharmD, MSN/NP, MPH, or related field. Bachelor’s degree in nursing, pharmacy, biological sciences, public health, or a related discipline may be considered with significant relevant pharmacovigilance, clinical safety, or drug development experience.
Typically 8 or more years of relevant experience in pharmacovigilance, clinical safety, drug safety science, clinical development, or a related function within biotechnology, pharmaceutical, or CRO settings; oncology and/or gene-mediated therapy experience preferred.
Strong working knowledge of global pharmacovigilance requirements and guidance, including ICH GCP, ICH E2 guidance, FDA IND safety reporting requirements, EU clinical trial safety reporting expectations, and Good Pharmacovigilance Practice principles.
Hands-on experience with safety databases, preferably Argus, including review of individual case safety reports, case narratives, medical coding, queries, workflow routing, and sponsor approval activities.
Demonstrated ability to review complex clinical and safety data, synthesize medical and scientific evidence, and prepare clear, balanced, well-supported written safety assessments.
Experience contributing to safety sections of clinical protocols, Investigator Brochures, DSURs, clinical study reports, safety monitoring plans, signal assessments, regulatory responses, and related clinical or regulatory documents.
Knowledge of signal detection and signal management practices, including aggregate review, case series evaluation, literature assessment, documentation of rationale, escalation of emerging safety issues, and governance support.
Excellent written and verbal communication skills, with the ability to translate complex medical, scientific, and regulatory information into concise recommendations for cross-functional teams and senior stakeholders.
Strong organizational skills and attention to detail, with the ability to manage multiple priorities, timelines, vendors, and deliverables in a small-company environment.
Collaborative, proactive, and accountable working style, with the ability to operate independently while maintaining close alignment with internal stakeholders and external partners.
All applicants must be authorized to work in the US and do not require sponsorship.

Nice To Haves

oncology and/or gene-mediated therapy experience preferred

Responsibilities

Perform sponsor review and approval of serious adverse event (SAE) and other individual case safety reports in Argus, including assessment of case completeness, medical consistency, query adequacy, coding accuracy, narrative quality, causality, expectedness, reportability, and required follow-up.
Author and contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-risk assessments, and safety summaries to support internal governance, regulatory submissions, Investigator Brochure updates, DSURs, clinical study reports, and other clinical or regulatory documents.
Support the implementation and continuous improvement of Candel’s signal management process and platform, including signal detection methodology, signal tracking, validation, prioritization, assessment, escalation, documentation, and inspection-ready recordkeeping.
Review safety data from clinical trials, safety databases, clinical databases, literature, nonclinical findings, and other relevant sources to identify emerging safety concerns, changes in frequency or severity of known risks, and other information relevant to ongoing benefit-risk evaluation.
Partner with Clinical Development and study teams to support protocol development, protocol amendments, safety monitoring plans, adverse event reporting sections, and other safety-related study documents.
Contribute to SAE reconciliation, safety data review meetings, Safety Management Team or Safety Governance Team activities, Data Monitoring Committee support, and cross-functional discussions related to patient safety and study conduct.
Support development and maintenance of Reference Safety Information, expectedness criteria, adverse event terms of special interest, product risk language, and other safety content used for expedited reporting and aggregate safety assessment.
Collaborate with PV vendors and CROs to ensure high-quality case processing, timely query resolution, accurate safety database documentation, compliance with safety management plans, and effective oversight of delegated pharmacovigilance activities.
Provide pharmacovigilance input to regulatory responses, health authority questions, inspection readiness activities, SOPs, work instructions, vendor oversight plans, training materials, and process improvement initiatives.
Maintain current knowledge of global pharmacovigilance regulations, ICH guidance, FDA requirements, EU GVP expectations, oncology safety considerations, MedDRA terminology, and evolving best practices in clinical safety surveillance.