Senior Director, Pharmacovigilance Operations

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

Reporting to the Senior Vice President, Global Drug Safety and Pharmacovigilance (DSPV), the Senior Director, Pharmacovigilance Safety Operations sets the tactical directions for the development, maintenance, and oversight for Pharmacovigilance Operations (including safety systems, processes, operational quality, and safety vendor arrangements) for all Kailera products throughout their lifecycle to ensure compliance with applicable regulatory requirements globally.

The Senior Director, Pharmacovigilance Safety Operations will lead and collaborate cross functionally to identify and drive forward pharmacovigilance strategies and efficiencies that support Kailera’s mission.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Lead and oversee the daily activities of the Pharmacovigilance Operations team
• Build, maintain, and oversee the infrastructure for the management of Individual Case Safety Reports (including SAEs/SUSARs), regulatory reporting, Global Safety Database, pharmacovigilance quality system, and aggregate report generation
• Establish and maintain the pharmacovigilance quality system through cross functional collaboration
• Oversee the functioning and continuous improvements of the Kailera Global Safety Database
• Provide functional oversight, including establishing and monitoring performance metrics for the safety vendor(s) and other outsourced activities
• Lead and collaborate cross functionally to ensure that relevant contracts, agreements, processes, training, and tracking are timely and adequate
• Represent DSPV on audits/inspections, provide and contribute to safety responses as needed
• Oversee and contribute to the management of deviations and CAPAs as related to pharmacovigilance operations
• Lead and actively contribute to the preparation and implementation of pharmacovigilance procedural documents
• Ensure that adequate resources are in place for compliant and efficient safety operations
• Develop and maintain the Global DSPV Business Continuity Plan
• Ensure operational support to clinical development and other cross functional teams
• Lead the development of, and provide content to, fit-to-purpose pharmacovigilance training to internal and external partners
• Provide subject matter expertise for safety/technology strategies, design, implementation and enhancement of drug safety processes and systems
• Assist the SVP, Global DSPV with the planning and development of the overall pharmacovigilance team and function including departmental goals, organization, and budgeting
• Identify and implement innovative technical, procedural, or resourcing solutions to improve DSPV operational capabilities
• Other responsibilities as assigned

Required Qualifications:

• 10+ years of experience in global pharmacovigilance operations including at least 7 years in people leadership roles
• Working knowledge of the management of ICSR processing and reporting, periodic safety report generation, and safety databases (Argus, ArisG/LifeSphere Safety, or similar)
• Proven experience in establishing pharmacovigilance processes as well as planning and implementing organizational capabilities
• Experience in creating or managing pharmacovigilance operational documents such as SOPs/Work Instructions, or safety management plans
• Demonstrated experience in managing safety vendors or other service providers
• Working knowledge of relevant local and global regulatory requirements and guidance documents
• Strong ability to proactively identify operational risks and initiate/manage corrective actions and communicate outcome
• Strong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
• Ability to drive initiatives for process optimization and efficiency
• Strong project management skills with ability to influence and keep teams focused and motivated
• Strong ability to prioritize, multitask, and deliver quality results that meet