Manager, Patient Safety and Pharmacovigilance Operations Job at Kailera Therapeutics (Waltham)

Senior Manager, Patient Safety and Pharmacovigilance Quality

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Op...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 8+ years of experience in Drug Safety/Pharmacovigilance (specifically, PV quality and compliance, and/or operations) within the pharmaceutical or biotechnology industry
Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP, GxP)
Demonstrated experience in audits/inspections, quality investigations, or CAPA management
Proven ability to identify issues, analyze root causes, propose, and implement effective solutions
Strong organizational, time management, and project prioritization skills, including excellent verbal and written communication and interpersonal skills, and proficient computer skills, including Microsoft Word and Excel
Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment, and adaptable to changing priorities
Must be able and willing to travel on occasion
Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)

Job Responsibility

Monitor global regulatory requirements, procedures, and guidance (e.g., ICH, FDA, EMA, MHRA, TGA, and ICH-GCP/ICH-E2E guidelines, etc.) and assess impact on existing procedures and recommending updates
Develop and maintain quality metrics for PSPV operations (e.g., SAE case reconciliation, inline and retrospective ICSR review, etc.)
Identify process gaps and develop stage-appropriate solutions within PSPV and the safety vendor
Support the development and maintenance of PSPV departmental Key Performance Indicators (KPI), Key Quality Indicators (KQIs), and monthly compliance metrics
Develop and implement processes for the management of all PSPV procedures and controlled documents (e.g., Policies, SOPs, WIs)
Track PV deviations, compliance issues, or other quality events
Contribute to CAPA development, review, monitor, and trend root cause analyses and propose preventive actions
Partner with Quality Assurance and other key stakeholders and provide PSPV input into organizational initiatives (e.g. quality monitoring, system implementations/improvements, process changes, inspection readiness)
Contribute to the maintenance of PSPV Pharmacovigilance Agreements
Support PSPV document review activities (e.g., signal detection, DSUR, risk management plans, literature review, etc.)

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

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Sound knowledge of drug safety and the drug development process
Knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis and evaluation of safety data
Good presentation skills
Analytical and problem-solving skills
Clear understanding of the regulatory submission process
Proficient in database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills

Job Responsibility

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
Assist in development of project specific safety procedures, workflows and templates
Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
Delegate work as appropriate to Drug Safety Assistants
Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required

Patient Safety Associate I (Drug Safety Associate I)

At Parexel, we’re dedicated to improving patient health worldwide. As a Patient ...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Foundational knowledge of drug safety regulations and pharmacovigilance processes
Ideal candidate has 3+ years experience in Drug Safety
2+ years experience in a post marketing
Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
Strong attention to detail, organizational skills, and problem-solving ability
Effective communication and willingness to work in a collaborative team environment
Proficiency with MS Office and ability to learn safety systems/databases
Preference for those with Veeva Safety experience
Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience

Job Responsibility

Processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
Conducting comprehensive literature searches and reviews to identify safety signals
Supporting signal detection and management activities
Tracking and monitoring regulatory information updates
Assisting in preparing and executing regulatory submissions
Contributing to the development of aggregate reports and study-specific safety documents
Managing Medical and Product Dictionary activities where applicable
Maintaining compliance through quality reviews of safety deliverables
Generating metrics and performance indicators for safety operations
Investigating and documenting late deliverable incidents

Senior Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

MBBS or MD from a recognized medical school
2+ years of experience in ICSR medical review
Good understanding of medical terminology
Experience in pharmacovigilance, drug safety, or clinical practice
Basic clinical training (internship/residency completed)

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/ or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Principal Medical Writer, Patient Safety

Location

India , Remote, Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Strong analytical and problem-solving abilities, with the capability to independently evaluate complex data and draw meaningful conclusions
Exceptional communication skills, both verbal and written, including the ability to produce clear, concise, and accurate medical/scientific content
Excellent interpersonal and collaboration skills, fostering productive relationships with clients, cross-functional teams, and stakeholders
Effective organizational and prioritization skills, with the ability to manage multiple tasks enthusiastically and maintain attention to detail under tight timelines
Client-focused mindset, demonstrating flexibility, professionalism, and a proactive approach to meeting client expectations and expanding business opportunities
Strong negotiation and stakeholder management skills, ensuring alignment of resources, timelines, and deliverables across teams and departments
Cultural awareness and adaptability, enabling effective communication and collaboration in global, multicultural environments
Proficient in computer operations and IT tools, with expertise in web-based applications and familiarity with the Windows operating system and Microsoft Office suite (Word, Excel, PowerPoint)
Prior experience in pharmacovigilance, or related fields is preferred
Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts

Job Responsibility

Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions
Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges
Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution
Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents
Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities
Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns
Provides expert interpretation of complex safety data patterns and trends across product lifecycles
Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team
Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents
Leads safety evaluations for complex molecules and sensitive indications

Principal Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Expertise in drug safety and the drug development process
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex problems requiring in-depth evaluation
Ability to exercise judgment within broadly defined practices and policies
Good presentation and verbal/written communication skills
Good interpersonal skills
Client focused approach to work
Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections, Act as a Subject Matter Expert during Audits/inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Fulltime

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expert knowledge of drug safety regulations and pharmacovigilance processes
Strong analytical and problem-solving abilities
Excellent communication and presentation skills
Superior organizational and time management capabilities
Proficiency with pharmacovigilance systems and databases
Proven experience in safety case management and regulatory reporting
Proficiency with safety databases and data analysis
Strong knowledge of ICH guidelines and regional requirements
Demonstrated mentoring abilities and process improvement skills
Experience in pharmaceutical or healthcare environments

Job Responsibility

Maintain expert-level knowledge of safety profiles, labeling, and global regulations
Lead development of project-specific procedures and workflows
Provide technical guidance to junior team members
Prepare for and participate in audits and inspections
Analyze metrics and drive continuous improvement
Collaborate with cross-functional teams on safety deliverables
Identify risks and recommend mitigation strategies
Ensure compliant documentation and archiving
Lead project management including safety procedure development and database setup
Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

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Manager, Patient Safety and Pharmacovigilance Operations

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