Pharmacovigilance Assistant Job at PrimeVigilance (Guildford)

Pharmacovigilance Assistant

We are currently seeking an Administrative Assistant to join our diverse and dyn...

Location

Poland; Bulgaria , Warsaw; Sofia

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry)
Basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential
Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently
Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting
Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols
Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint)
Fluent in written and verbal English
Ability to work effectively independently and within a team environment and across global teams

Job Responsibility

Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes
Provide administrative support to project teams as required
Distribute reports to Sponsors, sites, and applicable ICON personnel
Coordinate setup of required systems and mailboxes during study startup
File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF
Maintain data entry for safety event and miscellaneous tracking logs for all current projects
Assist with organization and planning of meetings
Daily entry into, and maintenance of, appropriate tracking systems
Maintain project training records for all assigned project team members
Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

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

SaaS Manager, Customer Relations

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor of Science in computer or natural science, or a comparable education
Significant experience as a SaaS Manager
Experience within the Pharmacovigilance, Safety Reporting, or Clinical Trials area in a pharmaceutical, biotech, or CRO company is beneficial but not essential
Technical experience, such as general knowledge of database structures/models and with writing SQL queries, beneficial
Good knowledge of Computerised Software Validation (GAMP 5) and 21 CFR Part 11
Project management experience is preferable
Ability to train and support junior/new colleagues in daily activities
ability to lead small-medium projects with clearly defined scope
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Autonomous, concentrated, and highly organized with strong attention to detail and keen analytical skills – and the ability to efficiently multi-task and handle competing priorities

Job Responsibility

Acting as a key interface between customers and technical teams
Provide consulting, training and support on client-facing and internal projects as it relates to the organization’s safety tools, hosted services and other technology systems for Pharmacovigilance
Assist in designing, developing, implementing, improving, and maintaining technical solutions and service offerings for the Pharmacovigilance business area – in particular with its safety tools and technology systems for Pharmacovigilance, covering: Training materials development and conduct
Support during implementation and post go-live
Administer Safety Databases (Pharmacovigilance and Medical Information (MI) modules) and/or other Technology Systems for Pharmacovigilance – including with regards to database configuration and user account management
Provide second level support as part of the PTS Helpdesk

Fulltime

Assistant Manager, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

June 01, 2026

Requirements

University degree in Life Science
Minimum 10 years of experience and profound knowledge in the field of pharmacovigilance
Good communication skills (written and verbally)
capability to point out issues and provide potential options for solution in the area of expertise

Job Responsibility

To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects
To organize and perform training of the above-mentioned documents
Identification (Classification of references) of safety- relevant publications in the scientific literature. Provision of scientific input in the course of literature surveillance service
Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers
Medical assessment of literature reports into the safety database
Act as main contact for client/project management
The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required
Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
Acts as line manager of assigned staff
Manages project coordination and resource allocation within the projects

Fulltime

Associate Director, Pharmacovigilance Planning and Innovations

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, th...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
3+ years of project or program management experience in a regulated environment
Demonstrated project management skills with strong analytical and problem-solving capabilities
Exceptional communication, stakeholder engagement, and change management skills
Strong interpersonal, organizational, and strategic planning skills
Experience working with outsourced vendors or Contract Research Organizations (CROs)
Experience leading or supporting process improvement
Adaptable to changing priorities and across multiple clinical trials and deliverables
Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar

Job Responsibility

Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
Support resource forecasting, alliance management, and vendor oversight
Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
Ensure project outcomes align with PV strategy and broader corporate objectives
Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements

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 Administrative Assistant

The Senior Administrative Assistant position within BioMarin’s Pharmacovigilance...

Location

United States , San Rafael

Salary:

31.00 - 50.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Minimum 5 years’ administrative experience in the biotechnology or pharmaceutical industries
Experience supporting pharmacovigilance functions is highly desirable
Bachelor’s degree highly preferred
Must have SAP/SRM contract management experience
Advanced knowledge of Microsoft Office Suite, Concur, SharePoint, and other business tools
Strong written and verbal communication skills
Ability to manage multiple tasks and priorities in a fast-paced, deadline-driven environment while maintaining attention to detail
Commitment to meeting deadlines and ensuring thorough, accurate, and compliant work products
Demonstrated ability to work independently, quickly learn new tasks, and proactively anticipate departmental needs

Job Responsibility

Proactively schedule and organize meetings and conference calls
Oversee logistics for offsite meetings
Arrange all business travel
Prepare and process expense reports
Monitor and replenish departmental supplies
Serve as the point of contact for IT-related issues
Actively participate in GPS meetings
Maintain and coordinate calendars for GPS leadership
Submit and track department contract requests
Monitor and reconcile departmental invoices

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Patient Safety Associate

Deliver Excellence in Pharmacovigilance. Join Our Patient Safety Team as a Patie...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Health Science degree or equivalent
Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices
Good working knowledge of the regulatory requirements for managing and reporting adverse events in Philippines
Experience in clinical trial pharmacovigilance
Understanding of the applicable Australia, New Zealand and EU requirements
Highly developed service, communication, organisational and problem-solving skills
High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety)
Practical experience in SOP writing and document management

Job Responsibility

Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance
Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP)
Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures
Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria
Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance
Maintain the integrity of client safety data registered into the safety databases
Participate in internal and external audits
Perform literature surveillance and regulatory authority adverse event searches
Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements)

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Pharmacovigilance Assistant

PrimeVigilance

Location:
United Kingdom , Guildford

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 11, 2025

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