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

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

New

Case Management – Specialist (Device Safety)

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Drug Safety or Life Sciences experience
Master’s degree and 7 years of Drug Safety or Life Sciences experience
Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience
Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
Bachelor’s Degree in a health-care subject area or scientific field
Previous experience with a corporate intake system or safety database
Ability to successfully manage workload to strict timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment

Job Responsibility

Support interactions with business partners (license partners) and vendors for all case intake and processing activities
Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Provide audit & external inspection support
Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases
Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Responsible for raise of device/combination product case related issues

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

New

Summer Intern, Pharmacovigilance Systems

The Pharmacovigilance Systems Intern will support Drug Safety operations at Arro...

Location

United States , San Diego

Salary:

24.00 - 26.00 USD / Hour

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

Currently pursuing or recently completed a Bachelor’s or Master’s degree in Pharmacovigilance or a related discipline
Strong verbal and written communication skills
Excellent problem-solving and analytical skills
Ability to follow procedures and regulatory requirements
Excellent verbal and written communication skills, including comfort presenting in group settings
Strong problem-solving and organizational skills
Proficiency in Microsoft Office applications

Job Responsibility

Support safety systems configuration and maintenance, including updates, enhancements, and bug fixes
Troubleshoot system issues and assist with issue resolution in collaboration with safety and technical teams
Analyze new business and regulatory requirements and support configuration and testing activities
Configure and test new system requirements and updates to existing functionality
Perform operational tasks within Drug Safety operations, including case management support
Run listings, queries, and reports from the Elluminate application
Learn new systems and assist with day-to-day safety system activities
Support documentation and testing efforts to ensure compliance and system reliability

What we offer

competitive salaries and an excellent benefit package

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

New

Senior Director, Drug Safety Operations

The Senior Director, Drug Safety Operations will be provide leadership and direc...

Location

United States , San Diego

Salary:

280000.00 - 300000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

12+ years of experience in Drug Safety/Pharmacovigilance Operations
Bachelor of Science with an advanced degree in pharmacy, nursing or related healthcare field
Strong working knowledge of case management and processing
Experience in using ARGUS or other safety databases
Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications
Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
Working experience with Safety Databases (Argus, ArisG or other) is required
Knowledge of ICH E2B guidelines in clinical and post-marketing studies
Good leadership and organizational skills with the ability to perform multiple tasks efficiently and effectively

Job Responsibility

Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close
Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility
Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems
Prepare, support and track PVAs/SDEAs with partners
Monitor compliance with partner Safety related activities needed as per PVA/SDEA
Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors
Review vendor scope and assist with study level budgets as needed
Oversee submission activities for ICSRs and aggregate reports
Collaborate with vendors for TMF Safety documents filing and review

What we offer

competitive salaries and an excellent benefit package

Fulltime

Validation Manager

We are seeking a highly skilled and motivated Validation Manager to lead and coo...

Location

United Kingdom , Manchester

Salary:

Not provided

Alliance Medical Ltd

Expiration Date

Until further notice

Requirements

Degree in a relevant scientific discipline (preferably MSc/PhD in Chemistry)
Minimum 5 years’ experience in product and process validation within a radiopharmaceutical setting
Proven managerial or supervisory experience with successful project delivery
Demonstrated ability to develop staff in validation practices
Proficient in Microsoft Word, Excel, PowerPoint, Project
Strong written and verbal communication skills
Familiarity with PrOFS and product ordering systems
Excellent interpersonal and organisational skills
Detail-oriented, proactive, and self-motivated
Strong regulatory knowledge (GMP, Safety)

Job Responsibility

Collaborate with the Head of Operations RP UK and Programme Manager to deliver validation activities across the UK RP network
Support Site Managers in planning and executing validation projects
Ensure appropriate staffing and provide training to support validation tasks
Coordinate with the Northern Europe team to streamline validation and introduce new products
Deliver technical training on new processes
Manage validation activities for new products/processes in compliance with GMP and pharmacopeia standards
Oversee the validation lifecycle and support regulatory submissions and audits
Generate validation documentation (VMP, URS, DQ, IQ, OQ, PQ, PV)
Create RQ protocols for new equipment/processes
Understand and manage RMS approval procedures and supplier additions

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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