Associate Director, Pharmacovigilance Planning and Innovations Job at Kailera Therapeutics (Waltham)

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

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

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)

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

Fulltime

Associate Director, Integrated Pharmacovigilance Operations

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Di...

Location

United States , Waltham, Massachusetts; San Diego, California

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

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

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

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

Fulltime

New

Sr. Product Engineer (Front-End) - Trips Team

Our organizers use WeTravel to win travelers by creating beautiful proposals and...

Location

Netherlands , Amsterdam

Salary:

Not provided

WeTravel

Expiration Date

Until further notice

Requirements

7+ years of software engineering experience (ideally full-stack) with strong product ownership mindset
Proficiency in building consumer-facing user experiences at scale, and expertise with at least one modern web application framework, ideally React/React Native
Proficiency with building and maintaining component libraries and working with a design system
Have experience building applications working with distributed systems, microservices and event-driven architecture and demonstrate strong systems thinking and can design for scalability
Have experience with operating applications in production, monitoring, and on-call responsibilities
Have excellent communication skills and experience working in multicultural, distributed teams
Experience using AI assistants like Cursor, Claude Code or GitHub Copilot for code generation and testing
Have experience leading projects and mentoring other engineers

Job Responsibility

Lead and build features end-to-end: from reviewing user interviews and product design, through architection and building systems to deployment and monitoring in production
Partner closely with our product team to discover user problems and shape their solutions – creating a world class experience for our organizers and travelers
Write high-quality, maintainable code across both frontend (TypeScript/React) and occasionally backend (Ruby on Rails)
Ensure our services are always on by building resilient applications, ensuring they are well monitored and mitigating incidents as an on-call/incident responder
Mentor teammates and contribute to WeTravel’s engineering practices and excellence

What we offer

Competitive salary
Generous "Time to Recharge" policy - enjoy unlimited paid time off
Work remotely for a maximum of 4 weeks per calendar year
2-week cross-functional onboarding program
Cycle-to-work scheme (Swapfiets subscription) or commuting reimbursement
Tuesday team lunches and after-work social events
Beautiful office in central Amsterdam - rooftop garden and right by Rokin metro
Extensive paid family leave
Three paid volunteer days per year
Cutting-edge equipment and tools to set you up for success

Fulltime

New

Store Associate

Retail Store Associates play a meaningful role within the CVS Health family. At ...

Location

United States , Broken Arrow

Salary:

15.00 - 18.00 USD / Hour

CVS Health

Expiration Date

April 12, 2026

Requirements

At least 16 years of age
Physical Requirements: Remaining upright on the feet, particularly for sustained periods of time
Lifting and exerting up to 35 lbs of force occasionally, up to 10 lbs of force frequently, and a negligible amount of force regularly to move objects to and from, including overhead lifting
Visual Acuity - Having close visual acuity to perform activities such as: viewing a computer terminal, reading, visual inspection involving small parts/details

Job Responsibility

Providing differentiated customer service by anticipating customer needs, demonstrating compassion and care in all interactions, and actively identifying and resolving potential service issues
Focusing on the customer by giving a warm and friendly greeting, maintaining eye contact and offering help locating additional items, when needed
Accurately perform cashier duties - handling cash, checks and credit card transactions with precision while following company policies and procedures
Maintaining the sales floor by restocking shelves, checking in vendors, updating pricing information and completing inventory management tasks as directed by store manager
Supporting opening and closing store activities, when needed
Providing customer support to all departments, including photo and beauty, ensuring departments are fully stocked and operational while remaining current with all updated services and tools
Assisting pharmacy personnel when needed, including working regular shifts in the pharmacy as part of opportunities for growth and career development
Embracing and advocating for new CVS services and loyalty programs that support our purpose of helping people on their path to better health

What we offer

Affordable medical plan options
401(k) plan (including matching company contributions)
Employee stock purchase plan
No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
Paid time off
Flexible work schedules
Family leave
Dependent care resources
Colleague assistance programs
Tuition assistance

Parttime

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Sales Account Executive, Mid Market

This role drives new business growth across the mid-market segment by owning a d...

Location

United States

Salary:

Not provided

Xbow

Expiration Date

Until further notice

Requirements

3+ years of experience in B2B SaaS sales, including time in a quota-carrying closing role
Proven success selling to mid-market customers
Track record of meeting or exceeding revenue targets
Experience selling technical products such as cybersecurity, DevOps, developer tools, or infrastructure software preferred
Hands-on experience using Salesforce and modern sales engagement tools

Job Responsibility

Own the full sales cycle for mid-market customers, from discovery through negotiation and close
Lead structured, consultative discovery conversations to uncover customer security challenges and priorities
Present and demo XBOW’s autonomous pentesting platform to security, engineering, and executive stakeholders
Manage opportunities through a defined sales process with accurate pipeline tracking and forecasting
Partner closely with SDRs on account strategy and opportunity qualification
Navigate multi-stakeholder evaluations, security reviews, and procurement workflows
Share customer feedback, competitive insights, and field learnings with Product and GTM leadership
Consistently meet or exceed quarterly and annual revenue targets

What we offer

Offers Equity
Offers Commission
Competitive base salary, performance-based commission, and equity participation
Clear opportunities for advancement within the sales organization

Fulltime

New

Trust & Safety Operations Analyst

At OpenAI, our Trust, Safety & Risk Operations teams safeguard our products, use...

Location

United States , San Francisco

Salary:

189000.00 - 280000.00 USD / Year

OpenAI

Expiration Date

Until further notice

Requirements

5+ years of experience in one or more of: trust & safety, fraud prevention, scam investigation, privacy/legal operations, compliance, or other risk/integrity domains ideally in a global or high-growth tech environment
Leverage OpenAI technology to enhance workflows, improve decision-making, and scale operational impact
Bring deep domain expertise in your specialization area and familiarity with relevant legal, policy, and technical frameworks
Have a track record of scaling operations, building processes, and working cross-functionally to improve performance and safety outcomes
Possess exceptional analytical skills able to detect patterns, assess risk, and recommend policy or product changes based on evidence
Communicate with clarity, empathy, and precision especially in sensitive user-facing contexts
Thrive in ambiguous, high-autonomy environments and balance speed with diligence
Are comfortable with frequent context switching, managing multiple projects, and prioritizing impact

Job Responsibility

Handle and resolve high-priority cases in your area of specialization (scaled content enforcement, fraud/scams, privacy/regulatory, or emerging risks)
Perform in-depth risk evaluations and investigations using internal tools, product signals, and third-party data
Act as incident manager for escalations requiring nuanced policy, legal, or regulatory interpretation
Partner with cross-functional teams to design and implement world-class operational workflows, decision trees, and automation strategies
Build feedback loops from casework to inform product, engineering, and policy improvements
Develop and maintain playbooks, SOPs, macros, and knowledge resources for internal teams and vendors
Lead or contribute to cross-functional projects, from zero-to-one process builds to global operational scale-ups
Monitor operational health through case quality audits, SLA adherence, escalation accuracy, and user satisfaction metrics
Train and support vendor teams, ensuring consistent quality and alignment with OpenAI’s trust and safety standards

What we offer

Medical, dental, and vision insurance for you and your family, with employer contributions to Health Savings Accounts
Pre-tax accounts for Health FSA, Dependent Care FSA, and commuter expenses (parking and transit)
401(k) retirement plan with employer match
Paid parental leave (up to 24 weeks for birth parents and 20 weeks for non-birthing parents), plus paid medical and caregiver leave (up to 8 weeks)
Paid time off: flexible PTO for exempt employees and up to 15 days annually for non-exempt employees
13+ paid company holidays, and multiple paid coordinated company office closures throughout the year for focus and recharge, plus paid sick or safe time (1 hour per 30 hours worked, or more, as required by applicable state or local law)
Mental health and wellness support
Employer-paid basic life and disability coverage
Annual learning and development stipend to fuel your professional growth
Daily meals in our offices, and meal delivery credits as eligible

Fulltime

New

Software Engineer

As a Software Engineer at NetApp, you will work as part of a team responsible fo...

Location

United States , Morrisville

Salary:

108800.00 - 162800.00 USD / Year

NetApp

Expiration Date

Until further notice

Requirements

Strong verbal and written communication skills are essential
Work collaboratively within a team environment of other engineers to meet aggressive goals and high quality standards
Development experience including design, implementation, documentation and maintenance of automation in Python, C or C++
Test automation and execution experience in Linux/Unix environment
Proven aptitude for learning new technologies
Familiarity with basic concepts of computer architecture, data structures and standard quality assurance practices
Ability to estimate work completion required to build an overall predictable plan
Creative and analytical approach to problem solving
Experience in virtual and cloud environments (AWS, Azure, GKE, OCI, etc…)
Experience with AI tooling in a software development environment

Job Responsibility

Be part of a highly productive team doing product planning, design, documentation, development, verification, validation and qualification of software
Actively participate in technical discussions within the team and with peer teams when evaluating and executing design and development plans for our software-defined and cloud product portfolio
A willingness to take on tasks and responsibilities that will contribute to team, department, and company business goals
Responsible for a mix of structured and unstructured tasks
Apply attained experiences and knowledge in solving routine to moderately complex problems
Interact primarily with direct manager and the technical lead on assigned projects. There may be communication with employees in other functions within the Business Unit as required
General direction is provided on routine work and detailed direction is provided on new projects and assignments. There will be on-going reviews of activities and priorities
Participate as an active contributor to team projects.

What we offer

Health Insurance
Life Insurance
Retirement or Pension Plans
Paid Time Off
various Leave options
Performance-Based Incentives
employee stock purchase plan
and/or restricted stocks (RSU’s)

Fulltime

New

Sous Chef

The Sous Chef is responsible for planning and directing food preparation in the ...

Location

United States , New York

Salary:

75000.00 - 90000.00 USD / Year

Schulson Collective

Expiration Date

March 20, 2026

Requirements

Degree from Culinary Arts school is preferred
may substitute additional experience for education
3 or more years in Kitchen Management
Prior experience in menu creation, recipe writing and coaching/training
Excellent written and verbal communication and problem-solving skills
Must be able to work flexible hours and days
Must exhibit top-notch teamwork
Leadership
Staff Development
Problem Solving

Job Responsibility

Hires, trains, develops and appraises staff effectively
Takes corrective action as necessary on a timely basis and in accordance with company policy
Consults with human resources as appropriate
Responsible for food costs and labor costs in assigned restaurant
Work with Executive Chef on developing new menu items, tastings and staying on top of trends
Responsible for developing relationships with vendors
Supervises hourly back of house staff and fills a role on the line or expo as needed
Schedules staff per business needs, files reports and monitors time & attendance as needed
Submits nightly reports on service, sales, labor & liquor costs, negative impressions, etc
Performs other duties as assigned

What we offer

Health Insurance
Dental Insurance
Vision Insurance
Paid Time Off
401k
Dining Discounts
Wellness Program

Fulltime

Associate Director, Pharmacovigilance Planning and Innovations

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 03, 2026

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