Associate Director, Pharmacovigilance Scientist

Title:
Associate Director, Pharmacovigilance Scientist

Location:
Remote or, Hybrid, Needham, MA

Salary: $184,000 - $200,000

At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.

Our Science:

Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate,it’san exciting time to join us and help bring transformative cancer treatments to patients. Learn more:

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.

The Associate Director, Pharmacovigilance Scientist will be responsible for the following:

• 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…