CrawlJobs Logo

Associate Director, Pharmacovigilance Scientist

kailera.com Logo

Kailera Therapeutics

Location Icon

Location:
United States , Waltham

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

160000.00 - 200000.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

The Associate Director, Pharmacovigilance Scientist will provide leadership, guidance, and support to signal management, benefit-risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle with focus on patients’ well-being and compliance with applicable regulatory requirements. Collaborate cross-functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.

Job Responsibility:

  • Perform and coordinate complex benefit-risk assessment and safety surveillance activities
  • Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
  • Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
  • Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
  • Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
  • Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
  • Perform safety signal management activities
  • conduct signal detection, author signal validation/evaluation reports, track and communicate findings
  • Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
  • Lead or assist with the preparation of Risk Management Plans (RMPs)
  • Contribute to responses to drug safety related health authority requests
  • Provide input into the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed
  • Contribute to the preparation of the safety sections of regulatory submission modules
  • Represents DSPV on audits/inspections and contributes to safety responses as needed
  • Contribute to responses to deviations and CAPAs as related to pharmacovigilance
  • Lead and actively contribute to the preparation and implementation of procedural documents as applicable to pharmacovigilance
  • Contribute as needed to the Global DSPV Business Continuity Plan
  • Provide content for pharmacovigilance training as needed
  • Contribute to the implementation of innovative technical or procedural solutions to improve DSPV safety surveillance capabilities
  • Other responsibilities as assigned

Requirements:

  • A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
  • Experience in safety data analysis, signal management, and benefit-risk evaluation
  • Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
  • Experience with authoring or contributing to aggregate safety reports, signal assessment reports
  • Working knowledge of relevant local and global regulatory requirements and guidance documents
  • Experience in creating or managing SOPs or Work Instructions
  • Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
  • Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
  • 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
  • Bachelors degree in life sciences
  • Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, health care or other related life sciences field is required. MD or Ph.D. degree is a strong plus

Nice to have:

  • Prior experience with contributing to clinical study or regulatory submission documents
  • Knowledge of drug/biologics development process
  • Experience with health authority pharmacovigilance inspections
  • Advanced degree strongly preferred
What we offer:
  • 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

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Icon
Kailera Therapeutics - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31694 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

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

Briefcase Icon

Similar Jobs for Associate Director, Pharmacovigilance Scientist

New

Sr. Data Engineer - Assistant Vice President

The Applications Development Senior Programmer Analyst is an intermediate level ...
Location
Location
United States , Irving
Salary
Salary:
107120.00 - 160680.00 USD / Year
https://www.citi.com/ Logo
Citi
Expiration Date
May 26, 2026
Flip Icon
Requirements
Requirements
  • 8+ years overall experience in a Big Data or Enterprise large scale Apps development using scalable tools like Databricks, Scala, Java and python ecosystem.
  • Minimum 5+ years of proven experience in a Data Engineering lead role with a strong focus on Big Data, data federation and data extractions data mesh architecture
  • Deep understanding of data modeling, data warehousing concepts, methodologies, and best practices.
  • Expertise in designing, building, and maintaining data pipelines using Big Data technologies such as Hadoop, Spark, Hive, Kafka, and related ecosystems.
  • Proficiency in at least one programming language commonly used for data engineering, such as Python, Java, or Scala.
  • Hands-on experience with ETL/ELT tools and Microservices frameworks.
  • Practical experience in applying AI/ML techniques to solve real-world problems.
  • Familiarity with microservices architecture and containerization technologies (e.g., Docker, Kubernetes).
  • Strong SQL skills and experience with relational databases.
  • Excellent communication, collaboration, and problem-solving skills.
Job Responsibility
Job Responsibility
  • Design, develop, and maintain scalable and efficient data pipelines using Big Data technologies (e.g., Hadoop, Spark, Kafka, Hive, Parquet, Avro) to ingest, process, and transform large volumes of structured and unstructured data.
  • Implement and optimize ETL/ELT processes for data ingestion, cleansing, transformation, and loading into data warehouses, data lakes, and other data stores.
  • Integrates subject matter and industry expertise within a defined area.
  • Applies in-depth understanding of how data engineering and analytics collectively integrate within the sub-function as well as coordinates and contributes to the objectives of the entire function.
  • Build and maintain data pipelines outcomes as data federations layers for lambda and Data Mesh architecture using tools like Starburst with strategy for adopting AI techniques-based use cases to drive efficiency and reduce data copies (e.g., machine learning, deep learning, natural language processing) to extract insights, automate processes, and enhance decision-making.
  • Develop and deploy microservices-based architectures to support data-intensive applications and ensure scalability, resilience, and maintainability.
  • Ensure data quality, integrity, and security throughout the data lifecycle.
  • Contribute to the continuous improvement of data engineering processes, standards, and best practices.
  • Effectively communicate technical concepts and solutions to both technical and non-technical audiences.
  • Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency, as well as effectively supervise the activity of others and create accountability with those who fail to maintain these standards.
What we offer
What we offer
  • discretionary and formulaic incentive and retention awards
  • medical, dental & vision coverage
  • 401(k)
  • life, accident, and disability insurance
  • wellness programs
  • planned time off (vacation)
  • unplanned time off (sick leave)
  • paid holidays
  • Fulltime
!
Read More
Arrow Right
New

Business Development Executive

We are seeking a confident and driven Business Development Executive to support ...
Location
Location
United Kingdom , Ringwood
Salary
Salary:
26000.00 - 28000.00 GBP / Year
https://www.office-angels.com Logo
Office Angels
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Confident communicator with strong telephone and email outreach skills
  • Ability to build rapport quickly with new and existing clients
  • Experience using CRM systems and maintaining accurate, up-to-date records
  • Strong attention to detail, particularly when cleansing and managing data
  • Proactive and self-motivated with a target-driven mindset
Job Responsibility
Job Responsibility
  • Research and identify new business opportunities and potential clients
  • Proactively contact new and lapsed clients to introduce or reintroduce company services and products
  • Build initial relationships with prospective clients and generate interest in offerings
  • Maintain and cleanse the CRM/database, ensuring all contact information is accurate and up to date
  • Qualify leads and pass relevant opportunities to the appropriate sales team members
  • Support the wider business development and sales teams with pipeline generation activities
  • Conduct market and competitor research to support business growth strategies
  • Track and update outreach activity, ensuring accurate reporting and follow-up actions
  • Assist with ad-hoc administrative and operational tasks as required
What we offer
What we offer
  • Team building events and socials
  • lots of professional development and progression opportunities
  • free parking
  • generous holiday allowance
  • Parttime
Read More
Arrow Right
New

Teaching Assistant

SEN Teaching Assistant | Make a Real Difference! Are you a passionate SEN Teachi...
Location
Location
United Kingdom , Caterham
Salary
Salary:
85.00 - 95.00 GBP / Day
https://www.randstad.com Logo
Randstad
Expiration Date
June 04, 2026
Flip Icon
Requirements
Requirements
  • Proven experience supporting children with SEN
  • Patient, empathetic, and resilient approach
  • Excellent communication and teamwork skills
  • Proactive, adaptable, and understanding of safeguarding
  • Right to work in the UK
  • Bonus: Relevant qualifications (e.g., TA L2/3)
  • experience with Makaton/PECS
  • or behaviour management
Job Responsibility
Job Responsibility
  • Provide vital 1:1 and small group support to students with diverse Special Educational Needs
  • help implement IEPs
  • adapt materials
  • foster an inclusive learning space
  • Fulltime
Read More
Arrow Right
New

Senior Data Engineer Lead / Architect - Senior Vice President

At Citi Services - Global Trade Technology Organization, we are on a mission to ...
Location
Location
India , Pune, Maharashtra, India, Chennai, Tamil Nadu, India
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 10+ years of professional experience in data engineering, with a proven track record of designing and building large-scale data systems
  • 3+ years in a technical leadership or architect role, with experience mentoring junior and senior engineers
  • Expert-level proficiency in at least one programming language (Python or Scala preferred) and exceptional SQL skills
  • Proven hands-on experience with Python or Scala for data manipulation, scripting, machine learning, and backend development
  • Deep, hands-on experience with a major cloud platform (AWS, GCP, or Azure) and its data ecosystem (e.g., S3/GCS, Redshift/BigQuery, EMR/Dataproc, Kinesis/Dataflow)
  • Extensive hands-on experience with modern big data technologies and Data streaming (like Hadoop, Hive, Impala, Apache Spark, Kafka, or Flink)
  • Proficiency with workflow orchestration tools such as Airflow, Dagster, or Prefect
  • Proficiency in designing and implementing microservices architectures, RESTful APIs, and event-driven systems with 'Data as a Product' Principle
  • Solid understanding of data modeling concepts and database design for both analytical (OLAP) and transactional (OLTP) workloads
  • Deep understanding and hands-on experience with relational databases (e.g., PostgreSQL, Oracle), NoSQL databases (e.g., MongoDB, Cassandra), data warehousing, and big data technologies (e.g., Spark, Kafka)
Job Responsibility
Job Responsibility
  • Architect & Design: Design, architect, and oversee the development of robust, scalable, and reliable data infrastructure, including data lakes, data warehouses, and real-time streaming platforms on the cloud
  • Build & Code: Act as a senior individual contributor and hands-on technical leader. Write clean, maintainable, and high-performance code for data ingestion, transformation, and serving layers (e.g., using Python, Scala, SQL, and Spark)
  • Lead & Mentor: Lead a team of data engineers, providing technical guidance, mentorship, and career development support. Foster a collaborative and inclusive team environment
  • Champion Culture: Define, document, and champion data engineering best practices across the organization, including CI/CD, data quality, testing frameworks, observability, and code review standards
  • Drive Strategy: Partner with leadership, product managers, data scientists, and analysts to understand data needs and develop a long-term data strategy and roadmap
  • Innovate & Evaluate: Stay at the forefront of data engineering technologies. Evaluate, prototype, and recommend new tools and frameworks to continuously improve our data platform
  • Ensure Governance: Implement and enforce robust data governance, security, and privacy policies in partnership with our security and compliance teams
  • Fulltime
Read More
Arrow Right
New

Sales Support

We are looking for a detail-oriented Sales Support team member to join a team in...
Location
Location
United States , Seattle
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in sales support, customer support, or a related administrative role within a business environment
  • Working knowledge of web-based platforms, internet navigation, browsers, and common digital communication tools
  • Strong written, verbal, and listening skills with the ability to communicate clearly and professionally
  • Proficiency with Microsoft Office and familiarity with collaboration and support platforms such as SharePoint and Zendesk
  • Experience using business systems such as CRM, CPQ, ERP, or similar enterprise applications
  • High attention to detail with the ability to enter data accurately, review records, and manage multiple tasks effectively
  • Ability to handle inbound requests, support billing or audit-related tasks, and work efficiently in a structured team setting
Job Responsibility
Job Responsibility
  • Enter and maintain accurate client and account information across internal systems and databases to support daily sales operations
  • Prepare client quotes and pricing documentation for direct requests and for members of the sales team
  • Respond to routine customer questions related to support needs and product information using Zendesk and standardized response templates
  • Review submitted information for completeness and accuracy before processing sales-related records and documentation
  • Support inbound communication by addressing basic inquiries and directing more complex issues to the appropriate teams
  • Use CRM, CPQ, ERP, and related business applications to assist with order support, record updates, and sales administration
  • Help monitor documentation and transactional details to ensure organized records and reliable follow-through on client requests
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Senior Administrator

Our client is a well-established and growing organisation with a strong commitme...
Location
Location
United Kingdom , Witham
Salary
Salary:
29000.00 - 32000.00 GBP / Year
https://www.office-angels.com Logo
Office Angels
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience within account management or a client focused role
  • Excellent communication and relationship building skills
  • Strong organisational skills with the ability to manage multiple priorities
  • A strategic mindset with the ability to identify improvements
  • Confidence in analysing performance data and providing insights
  • A collaborative team player with a strong focus on client service
Job Responsibility
Job Responsibility
  • Act as the main contact for client accounts, building strong relationships
  • Lead client meetings and oversee account performance
  • Resolve service issues and maintain high service standards
  • Identify opportunities to improve client experience and grow accounts
  • Support the Client Services Manager in achieving team goals
  • Work with internal teams, advisors, and surveyors to ensure timely delivery
  • Coordinate site visits and manage logistics and access requirements
  • Oversee quotations and ensure accurate processing of client instructions
  • Manage bespoke client needs and deliver against expectations
  • Identify inefficiencies and support process improvements
What we offer
What we offer
  • Onsite parking
  • 23 days holiday + bank holidays
  • Annual reviews
  • Great progression opportunities and training
  • Company socials
  • Fulltime
Read More
Arrow Right
New

Senior Day Care Assistant

Make a difference every day and give back to your community! This role will be b...
Location
Location
United Kingdom , Swadlincote
Salary
Salary:
13.85 - 14.92 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Prior experience as a Care Assistant or Support worker
  • patient, understanding and respectful of resident's individual abilities
  • genuine caring nature
  • desire to make a real difference for residents
Job Responsibility
Job Responsibility
  • Leading, managing and supporting your care team ensuring high quality of care and service is always provided to all residents
  • Ensuring care plans are regularly reviewed continuous assessment, planning, implementation and evaluation of resident's care
  • Engaging with residents in conversation at a level and pace that values the individual and respects their dignity and communication differences
  • Administering and recording medication as prescribed, with accurate monitoring of drug dose to the residents in the home
  • To ensure that each resident's dignity and independence is always preserved and promoted
  • To encourage each resident to achieve the highest possible quality of life that is right for them
  • To encourage and assist residents to participate in any discussion relating to their daily living arrangements
  • To assist where necessary with each resident's personal care
  • Fulltime
Read More
Arrow Right
New

Director of Business Services

This is not a traditional "B2B Sales Director role". This is a significant growt...
Location
Location
United Kingdom , Abingdon
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • You will be a commercial leader who can evidence building and scaling growth businesses in Telecoms, Infrastructure, Technology, or similar sectors.
Job Responsibility
Job Responsibility
  • Lead and build a materially larger and commercially successful business on top of an established infrastructure platform
  • Rethink how we expand our presence across business markets, where we compete, how we serve, how we take products to market and where we can create successful partnerships to accelerate growth
  • Combine strategic thinking with action and execution
  • Spot the opportunities, then build the commercial model and sales strategy to capture them
  • Build and grow a business intelligently and sustainably.
What we offer
What we offer
  • Generous employer pension
  • up to 8% matched contribution
  • Income protection & life assurance
  • 25 days holiday (plus bank holidays), holiday purchase scheme and Yay Days!
  • Health cash plan, 24/7 remote GP access and Employee Assistance Programme including counselling & legal advice
  • Unlimited access to online training and development content via our Learning Management System
  • Long service benefits and monthly employee recognition
  • Enhanced maternity and paternity provisions
  • Flexible working environment
  • Health & Wellbeing initiatives and company funded social events.
  • Fulltime
Read More
Arrow Right