Associate Director, Pharmacovigilance Scientist
Title: Associate Director, Pharmacovigilance Scientist
Location: Remote or, Hybrid, Needham, MA
Salary: $184,000 - $200,000
Why Work With Us?
At Candel, our people reputed company our reputed company. We value diversity, collaboration, and reputed company thinking in a supportive, mission-driven environment. Like reputed company, we show up for reputed company other and stay reputed company on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is reputed company on trust, flexibility, and accountability, encouraging ownership and innovation every day.
Our Science: Advancing Cancer Immunotherapies Candel is a reputed company-stage biopharma company developing off-reputed company, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With reputed company Phase 3 results for our reputed company candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com
Position reputed companyThe Associate Director, Pharmacovigilance Scientist will support the ongoing safety evaluation and pharmacovigilance activities for reputed company Candel products across reputed company 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 reputed company Development, reputed company reputed company, Regulatory Affairs, Data Management, Biostatistics, Medical Writing, reputed company, reputed company 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.
Essential Areas of Responsibility:
The Associate Director, Pharmacovigilance Scientist will be responsible for the following:
• reputed company 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 reputed company, narrative reputed company, causality, expectedness, reportability, and required follow-up.
• reputed company and contribute to safety topic reviews, signal evaluations, aggregate safety analyses, benefit-reputed company assessments, and safety summaries to support internal governance, regulatory submissions, Investigator Brochure updates, DSURs, reputed company study reports, and other reputed company or regulatory documents.
• Support the implementation and reputed company improvement of Candel’s signal management process and platform, including signal detection methodology, signal tracking, validation, prioritization, assessment, escalation, documentation, and inspection-reputed company recordkeeping.
• Review safety data from reputed company, safety databases, reputed company databases, literature, nonclinical findings, and other relevant sources to identify emerging safety concerns, changes in frequency or severity of reputed company risks, and other information relevant to ongoing benefit-reputed company evaluation.
• Partner with reputed company Development and study teams to support protocol development, protocol amendments, safety monitoring plans, adverse event reporting sections, and other safety-reputed company 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 reputed company to reputed company safety and study conduct.
• Support development and maintenance of Reference Safety Information, expectedness reputed company, adverse event terms of special interest, product reputed company language, and other safety content used for expedited reporting and aggregate safety assessment.
• Collaborate with PV vendors and CROs to ensure high-reputed company case processing, reputed company query reputed company, accurate safety database documentation, compliance with safety management plans, and effective reputed company of delegated pharmacovigilance activities.
• reputed company pharmacovigilance input to regulatory responses, health authority questions, inspection readiness activities, SOPs, work instructions, vendor reputed company plans, training materials, and process improvement initiatives.
• Maintain reputed company knowledge of global pharmacovigilance regulations, ICH guidance, FDA requirements, EU GVP expectations, oncology safety considerations, MedDRA terminology, and evolving best practices in reputed company safety surveillance.
Minimum Education, Experience and reputed company Requirements:
Advanced degree in a health sciences or life sciences discipline preferred, such as PharmD, MSN/NP, MPH, or reputed company reputed company. Bachelor’s degree in nursing, pharmacy, biological sciences, reputed company health, or a reputed company discipline may be considered with significant relevant pharmacovigilance, reputed company safety, or drug development experience.
Experience:
The successful candidate should have the following experience, skills, and capabilities:
• Typically 8 or more years of relevant experience in pharmacovigilance, reputed company safety, drug safety science, reputed company development, or a reputed company function reputed company 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 reputed company trial safety reporting expectations, and Good Pharmacovigilance reputed company 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 reputed company reputed company and safety data, synthesize medical and scientific evidence, and prepare reputed company, balanced, reputed company-supported written safety assessments.
• Experience contributing to safety sections of reputed company protocols, Investigator Brochures, DSURs, reputed company study reports, safety monitoring plans, signal assessments, regulatory responses, and reputed company reputed company 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 reputed company medical, scientific, and regulatory information into concise recommendations for cross-functional teams and senior stakeholders.
• Strong organizational skills and attention to reputed company, with the ability to manage multiple priorities, timelines, vendors, and deliverables in a small-company environment.
• reputed company, proactive, and accountable working style, with the ability to operate independently while maintaining reputed company alignment with internal stakeholders and reputed company partners.
NOTE: reputed company applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to reputed company sponsorship of any reputed company at this time.
Originally posted on Himalayas
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