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

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

Patient Access Navigator

Amgen has an exciting opportunity for an experienced, energetic & patient-focuse...

Location

Canada

Salary:

85035.00 - 103438.00 CAD / Year

Amgen

Expiration Date

Until further notice

Requirements

Bachelors Degree with 2 years of related experience
College diploma and 4 years of related experience
Nursing background is a must
2+ years of patient support/reimbursement experience or 3 years of relevant work experience in a “high service culture”
Experience with Patient Support Programs
Familiarity with Heath Canada requirements
Organized, detail oriented with strong service-based mindset
Experience with Salesforce or other relevant CRM systems
Multi-tasking, prioritization and proactive problem-solving abilities
Strong analytical skills and strategic mindset

Job Responsibility

Responsible for enrolling and onboarding patients into an Amgen Patient Services Program
Liaise with patient’s relevant health care providers to support patient’s access to therapy and support services
Provide logistical, non-medical educational assistance to patients and caregivers as well as office and site of care staff, including physicians, nurses and/or office managers
Able to work collaboratively and harmoniously with: Amgen Patient Services Team members and cross-functional partners who have roles supporting the patient journey, Third Party PSP team members at Patient Program HUB and other decentralized PSP partners
Establish milestones and checkpoints to ensure successful work/project completion
follows up on work efforts and takes corrective steps when needed to ensure work remains on track
Responsible for supporting patients to navigate reimbursement access for their prescribed Amgen therapy, including, reimbursement investigation, facilitating insurance coverage documentation, coordination of benefits, & financial assistance
Coordinate Free of Charge Goods (FOCG) for patients who are eligible
Coordinating bridging to reimbursement for patients who meet eligibility requirements
Facilitate patients access to reminder services

What we offer

Competitive and comprehensive total compensation programs aligned with local industry standards

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

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

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

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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