Director, Drug Safety and Pharmacovigilance

The Role :

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Agenus is searching for a collaborative, resourceful, and innovative PV Scientist to work in conjunction with the Safety Medical team to provide scientific / clinical expertise, strategic input, support for deliverables and activities associated with signal management activities, aggregate reports, benefit-risk evaluations for assigned products, and providing support and assistance in crafting responses to regulatory authorities as appropriate.

As the Director of Drug Safety and Pharmacovigilance, you will play a key role in characterizing the safety profiles of Agenus’ compounds and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing).

This role will conduct and oversee cross-functional Signal Detection and Safety Surveillance, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed.

This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous cross-functional departments.

You will interact with stakeholders ranging from colleagues at Agenus to regulatory authorities. This role will report to the Head of Safety and Pharmacovigilance.

In the role you will :

• Perform safety review of Adverse Event reports for Agenus products.
• Perform ongoing surveillance (including signal detection / evaluation) of Agenus clinical trials and post marketing safety data
• Lead active monitoring and continual assessment of safety profiles through systematic signal detection and critical review of aggregate safety data from various sources
• Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues.
• Provide safety review and safety science to various documents including but not limited to : Protocols, IBs, ICFs, SAPs / TFLs, Medical Monitoring Plans, CSRs, ad-hoc safety queries, health authority questions, etc.

You will also be contributing to the development of other documentation such as : Investigator’s Brochures, and Subject Informed Consent

• Proactively resolve issues, propose solutions, and escalate to PSL accordingly.
• Signal assessment strategy and assess potential impact to the product safety profile with recommendation for action.
• Collaborate with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities.
• Lead authorship of aggregate reports, exercising judgment in method selection and networking with cross-functional stakeholders to ensure high-quality and timely submissions.
• Collaborate with the clinical development team to develop and implement a comprehensive safety surveillance strategy for clinical trials across different platforms.
• Help perform in-depth evaluation of safety data from multiple sources to support product safety surveillance and signal detection activities, partner queries, and health authority requests.

Support internal PV audits, regulatory inspections, updates to safety management plans, and Sponsor training materials.

• Author and contribute to SOPs, WIs, and corporate policies to maintain a state of inspection readiness.
• Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections.
• Conduct signal detection, including adverse event data, literature and other sources in collaboration with PV Physician and according to Agenus Signal Management and Safety Governance process.
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
• Manage and prioritize safety signals, ensuring effective risk mitigation and response.
• Perform data analysis to evaluate safety signals and prepare written signal analysis reports.
• Collaborates with Safety Medical for signal detection activities including monthly SAE reviews, bi-annual clinical and safety reviews, and any ad hoc analysis as appropriate.
• Project Management of periodic aggregate safety reports (e.g. PBRERs, DSURs), as well as reviewing the content and authoring of portions of these documents.
• Evaluate and document safety assessment, and if warranted, prepare safety assessment reports and other safety documents and regulatory responses.
• Prepare and present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.
• Collaborate with other functional areas to achieve business goals and objectives.

Qualifications : About You

• 8+ years in pharmacovigilance in an analytical role as a MD, PharmD, or PhD in a medical field or biological science
• Safety Scientist for products in the clinical trial and post-marketing environments
• Experience within the field of oncology is preferred and / or first human trials.
• Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
• Prior experience as a Safety Scientist and competency around safety scientist core responsibilities including :
• Signal detection and signal management strategy and execution.
• Aggregate safety analysis with a particular focus on early development for Phase I, Phase II / III, and filing pharmacovigilance activities.
• Experienced with FDA / EMA regulations and ICH guidance governing pharmacovigilance and risk management.
• Documented experience from overseeing multiple trials with safety inputs at the Global level.
• Sound strategic evaluation, analysis, and decision-making skills.
• Ability to work effectively in a dynamic, complex, and fast-paced team environment.

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