What You’ll Do:

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Director, Integrated Pharmacovigilance Operations will support the implementation and maintenance of pharmacovigilance operational activities across the pipeline, including safety vendor oversight, procedural document development, pharmacovigilance quality management, and cross functional collaborations. The Associate Director will contribute to pharmacovigilance strategies and efficiencies and the buildout of the pharmacovigilance and safety team in support of Kailera’s mission.

Required location: Waltham, MA or San Diego, CA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
• Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
• Assist with data reconciliation and support safety signal management and aggregate data review activities
• Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
• Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
• Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
• Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
• Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
• Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
• Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions
• Support the development and maintenance of inspection readiness activities, identify and participate in process improvement initiatives
• Assist in GCP and GVP inspection readiness and support audits

Required Qualifications:

• A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
• Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
• Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
• Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
• Demonstrated understanding of safety databases, medical literature, and electronic data capture technology
• Working knowledge of validated drug safety databases and MedDRA coding dictionary
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera
• Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals

Preferred Qualifications:

• Experience in other areas of drug development such clinical trial management, regulatory, or quality assurance is a plus

 

Education:

• Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required. MD, PhD, PharmD, RN or Master’s degree is a plus