Senior Director, Pharmacovigilance Operations

Senior Director, Pharmacovigilance Operations

Waltham, Massachusetts

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 :

Preferred Qualifications :

Education :

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range

$210,000 - $270,000 USD

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION :

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify :

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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