Atlas Venture
Senior Director, Pharmacovigilance Operations
Atlas Venture, Waltham, Massachusetts, United States, 02254
Senior Director, Pharmacovigilance Operations
Company Address:
890 Winter Street Suite 220, Waltham, MA 02451
About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions.
Job Description 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 tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly
Preferred Qualifications
Experience in other areas of drug development such as clinical trial management, regulatory, quality assurance or medical affairs is a plus
Education
MD, PhD, PharmD, RN or Master’s degree or equivalent in Public Health, Epidemiology or other life sciences is required
Benefits Benefits of Working at Kailera
Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. 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 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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Company Address:
890 Winter Street Suite 220, Waltham, MA 02451
About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions.
Job Description 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 tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly
Preferred Qualifications
Experience in other areas of drug development such as clinical trial management, regulatory, quality assurance or medical affairs is a plus
Education
MD, PhD, PharmD, RN or Master’s degree or equivalent in Public Health, Epidemiology or other life sciences is required
Benefits Benefits of Working at Kailera
Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. 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 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.
#J-18808-Ljbffr