CrawlJobs Logo

Associate Director, Integrated Pharmacovigilance Operations

kailera.com Logo

Kailera Therapeutics

Location Icon

Location:
United States , Waltham, Massachusetts

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

160000.00 - 200000.00 USD / Year

Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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
  • Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required

Nice to have:

  • Experience in other areas of drug development such clinical trial management, regulatory, or quality assurance is a plus
  • MD, PhD, PharmD, RN or Master’s degree is a plus
What we offer:
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • a year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Associate Director, Integrated Pharmacovigilance Operations

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...
Location
Location
United States
Salary
Salary:
180000.00 - 195000.00 USD / Year
apogeetherapeutics.com Logo
Apogee Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in life sciences or equivalent
  • 8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
  • 2+ years’ experience in Biotech industry strongly preferred
  • Significant knowledge of pharmaceutical industry, drug development and regulatory processes
  • Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
  • Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
  • Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
  • Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
  • High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
  • Work comfortably in a fast-paced, dynamic work environment and embrace change
Job Responsibility
Job Responsibility
  • Accountable for overall management of multiple clinical trials
  • Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
  • Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
  • Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
  • Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
  • Responsible for preparing and/or presenting to executive management as delegated
  • Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
  • May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
  • Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
  • In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc
What we offer
What we offer
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
  • Fulltime
Read More
Arrow Right

Associate Director, Clinical Quality Assurance

Playing a critical hands-on role within Kailera, the Associate Director, Clinica...
Location
Location
United States , Waltham
Salary
Salary:
160000.00 - 200000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 10+ years of experience in FDA regulated industry
  • Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
  • A strong customer focus and ability to prioritize and adapt to business needs are required
  • Strong business partner with a focus on collaborating and delivering results
  • Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
  • Understanding and knowledge of applicable industry regulations
  • Ability to interact constructively and efficiently within and across functional areas and management
  • Ability to resolve day-to-day issues efficiently while maintaining compliance
  • Clear, concise writing skills and good verbal communication and presentation skills
  • Comply with Company quality standards/SOPs and implementation of new quality systems
Job Responsibility
Job Responsibility
  • In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies
  • Monitor and track quality metrics to identify trends and areas of improvement
  • Ensure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness
  • Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program
  • Plan, coordinate, review and approve internal, external, and clinical site audits using risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations
  • Assess audit findings and develop corrective and preventative actions (CAPA)
  • Lead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA
  • Ensure that investigations are conducted in a timely and thorough manner, following established procedures
  • Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections
  • Provide guidance and support to cross-functional teams during Health Authority inspections
What we offer
What we offer
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • Fulltime
Read More
Arrow Right
New

Specialist SEN Support Assistant

Are you ready to be the "anchor" for a child with complex needs? Randstad Educat...
Location
Location
United Kingdom , Crawley
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 25, 2026
Flip Icon
Requirements
Requirements
  • Background in supporting ASD, ADHD, or SEMH is essential
  • Level 2/3 TA qualification is preferred, but relevant experience is key
  • Composed during high-pressure situations
  • Reliable for a consistent, long-term placement
Job Responsibility
Job Responsibility
  • 1:1 Support: Implement EHCP goals to help students reach specific developmental milestones
  • Behavioural Mentoring: Use de-escalation and regulation techniques to manage sensory or emotional triggers
  • Foster Independence: Guide students through social interactions and daily routines to build self-reliance
  • Personal Care: Provide dignified assistance with personal care when required
What we offer
What we offer
  • Steady Routine: Fixed Monday-Friday hours in a single Crawley school
  • Professional Growth: Free specialist training, including Safeguarding and Team Teach
  • Real Impact: The reward of seeing long-term progress in a child's life
  • Referral Bonus
Read More
Arrow Right
New

Year 5 Class Teacher

Year 5 Class Teacher | Long-Term Placement. The Opportunity: Are you a Year 5 sp...
Location
Location
United Kingdom , East Grinstead
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 26, 2026
Flip Icon
Requirements
Requirements
  • Qualified Teacher Status (QTS)
  • Strong knowledge of the Year 5/6 curriculum and experience preparing students for the transition to Year 6
  • A team player who works effectively with TAs and the wider school community
  • A thorough understanding of child protection protocols and KCSiE guidelines
Job Responsibility
Job Responsibility
  • Plan and teach the Year 5 curriculum, with a strong focus on deepening comprehension in Literacy and fluency in Numeracy
  • Differentiate tasks to challenge high-achievers while providing vital support for students with SEN or EAL requirements
  • Implement consistent behavior management strategies to maintain a focused and positive learning environment
  • Regularly track pupil progress and use data to bridge learning gaps through targeted interventions
What we offer
What we offer
  • Weekly PAYE: Transparent pay with no hidden umbrella fees
  • Career Growth: Access to our free CPD library, including specialized behavior management and SEND workshops
  • Local Insight: A dedicated consultant with expert knowledge of schools in East Grinstead and the surrounding West Sussex area
  • Refer-a-Friend: Earn £300 in vouchers for every teacher you refer to us
Read More
Arrow Right
New

Specialist SEN Support Assistant

Are you ready to be the "anchor" for a child with complex needs? Randstad Educat...
Location
Location
United Kingdom , Crawley
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 25, 2026
Flip Icon
Requirements
Requirements
  • Background in supporting ASD, ADHD, or SEMH is essential
  • Level 2/3 TA qualification is preferred, but relevant experience is key
  • Experience in supporting learners with Autism (ASD), ADHD, and SEMH needs
  • Composed and resilient
  • Reliable and looking for a consistent, long-term placement
Job Responsibility
Job Responsibility
  • 1:1 Support: Implement EHCP goals to help students reach specific developmental milestones
  • Behavioural Mentoring: Use de-escalation and regulation techniques to manage sensory or emotional triggers
  • Foster Independence: Guide students through social interactions and daily routines to build self-reliance
  • Personal Care: Provide dignified assistance with personal care when required
What we offer
What we offer
  • Steady Routine: Fixed Monday-Friday hours in a single Crawley school
  • Professional Growth: Free specialist training, including Safeguarding and Team Teach
  • Real Impact: The reward of seeing long-term progress in a child's life
  • Referral Bonus
Read More
Arrow Right
New

Primary Teaching Assistant

Are you a compassionate and driven individual dedicated to helping young learner...
Location
Location
United Kingdom , Crawley
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 26, 2026
Flip Icon
Requirements
Requirements
  • Proven experience in working with children (Primary school experience is a major plus)
  • A patient, adaptable, and nurturing approach to student support
  • Effective communication and ability to collaborate with teachers and build rapport with pupils
  • A dedicated focus on child safety (An enhanced DBS check is required)
Job Responsibility
Job Responsibility
  • Break down complex teacher instructions into manageable steps for students
  • Provide focused 1:1 or small group attention to pupils who require extra help
  • Support students with diverse learning requirements (ASD, ADHD, SEMH) to ensure they are fully included
  • Prepare creative learning resources
  • Ensure the classroom remains an organized, welcoming space
What we offer
What we offer
  • Competitive Pay
  • Work-Life Balance (term-time-only schedule)
  • Professional Growth (access to tailored training and CPD opportunities)
  • Local Network (collaborative community of schools across West Sussex)
  • Referral Bonus
Read More
Arrow Right
New

Primary Teaching Assistant

Are you a compassionate and driven individual dedicated to helping young learner...
Location
Location
United Kingdom , Crawley
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 26, 2026
Flip Icon
Requirements
Requirements
  • Proven Experience: A background in working with children (Primary school experience is a major plus)
  • The 'Right' Traits: A patient, adaptable, and nurturing approach to student support
  • Effective Communication: The ability to collaborate with teachers and build quick rapport with pupils
  • Safeguarding First: A dedicated focus on child safety. (An enhanced DBS check is required)
Job Responsibility
Job Responsibility
  • Instructional Support: Break down complex teacher instructions into manageable, 'bite-sized' steps for students
  • Targeted Intervention: Provide focused 1:1 or small group attention to pupils who require extra help to meet their learning goals
  • SEN Integration: Support students with diverse learning requirements (ASD, ADHD, SEMH) to ensure they are fully included
  • Classroom Coordination: Prepare creative learning resources and ensure the classroom remains an organized, welcoming space
What we offer
What we offer
  • Competitive Pay: Rates that reflect your hard work and dedication
  • Work-Life Balance: Enjoy a term-time-only schedule that fits your lifestyle
  • Professional Growth: Access to tailored training and CPD opportunities to help you progress
  • Local Network: Become part of a collaborative community of schools across West Sussex
  • Fulltime
Read More
Arrow Right
New

Primary Teaching Assistant

Are you a compassionate and driven individual dedicated to helping young learner...
Location
Location
United Kingdom , Crawley
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
May 26, 2026
Flip Icon
Requirements
Requirements
  • Proven experience in working with children (Primary school experience is a major plus)
  • A patient, adaptable, and nurturing approach to student support
  • Effective communication and collaboration with teachers
  • Ability to build quick rapport with pupils
  • Dedicated focus on child safety
  • An enhanced DBS check is required
Job Responsibility
Job Responsibility
  • Break down complex teacher instructions into manageable steps for students
  • Provide focused 1:1 or small group attention to pupils who require extra help
  • Support students with diverse learning requirements (ASD, ADHD, SEMH) to ensure they are fully included
  • Prepare creative learning resources
  • Ensure the classroom remains an organized, welcoming space
What we offer
What we offer
  • Competitive pay
  • Term-time-only schedule
  • Access to tailored training and CPD opportunities
  • Local network in a collaborative community of schools across West Sussex
  • Referral Bonus
  • Fulltime
Read More
Arrow Right