Pharmacovigilance Project Manager Job at PrimeVigilance (Guildford)

Manager, Local Pharmacovigilance

The Manager of Local Pharmacovigilance is responsible for the execution of opera...

Location

Belgium , Mechelen

Salary:

Not provided

AmerisourceBergen

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Ability to train and support junior/new colleagues in daily activities
ability to lead small project 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
Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

Clinical Project Manager

Permanent position available immediately located in Paris. The role involves lea...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Holder of additional training in methodology (CESAM, IUD, …)
Successful experience of Clinical Project Manager in a pharmaceutical company or CRO
6-8 year’s experience in clinical development (Phase II and III)
Experience in oncology or autoimmune inflammatory diseases would be a plus
Experience in international development required
Experience of the regulatory environment for clinical trials
Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
Fluent in English

Job Responsibility

Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing
Plan the clinical development program
Prepare studies protocols, amendments and reports
Prepare regulatory dossiers
Manage relationships with investigators and opinion leaders

What we offer

Salary and package to define according to skills and experience

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

Senior IT Engineer – Research & Development

The Senior IT Engineer – R&D acts as the interface between the R&D business unit...

Location

Italy , Bologna; Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor's or Master’s Degree in Information Technology, Statistics, Biotechnology or other relevant field
4–6 years of experience in IT in the Life Sciences/Biotech/Pharma sector
Solid understanding of IT R&D processes and/or application management with a proven track record of delivering results across multiple project settings
Strong understanding of the R&D Pharma environment and experience in one or multiple areas such as e.g. Clinical, Pharmacovigilance, Regulatory, Medical Affairs
Knowledge of R&D software such as electronic Trial Master Files, Clinical Data Management solutions, Pharmacovigilance and Regulatory applications
Experience with GxP and GAMP5 frameworks
Proven experience in managing vendor relationships
Familiarity with Agile, Scrum, and/or Waterfall methodologies and ideally Project Management tools (e.g. SmartSheet, Microsoft Project)
Proficiency in Microsoft Office Suite
Strong communication and stakeholder management skills

Job Responsibility

Collect and analyze business requirements from R&D stakeholders
Translate business needs into functional and technical specifications
Collaborate with IT teams (architecture, development, support) to evaluate feasibility and define solution proposals for R&D use cases
Support the management of software implementations and data migration projects for the R&D solutions’ portfolio
Support the prioritization of initiatives based on business value, urgency, and alignment with strategic objectives
Contribute to the evaluation and development/implementation of AI initiatives for R&D use cases
Monitor the demand pipeline and maintain a clear overview of ongoing and planned IT R&D initiatives
Facilitate workshops and meetings between business and IT to ensure shared understanding and alignment
Contribute to building business cases for new IT R&D initiatives
Support change management activities and user adoption of delivered solutions

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

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

Gvp compliance lead

BioMarin is looking for an individual with experience working in Pharmacovigilan...

Location

United States

Salary:

176000.00 - 242000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Head of Regulatory Affairs

The Head of Regulatory Affairs is responsible for providing strategic leadership...

Location

India , Chennai

Salary:

Not provided

Randstad

Expiration Date

February 15, 2026

Requirements

Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field
Minimum of 10-15 years of experience in Regulatory Affairs
At least 5 years in a leadership role within a CRO or biopharmaceutical organization
Proven experience in global regulatory submissions and interactions with major health authorities (FDA, EMA, MHRA, CDSCO, etc.)
In-depth understanding of clinical development, GCP, and ICH guidelines
Strong track record in managing teams and leading complex regulatory projects across multiple therapeutic areas
Exceptional leadership, communication, and negotiation skills
Ability to translate complex regulatory requirements into practical strategies
Strong client relationship management and presentation abilities
High attention to detail with strong organizational and problem-solving skills

Job Responsibility

Develop and implement the CROs regulatory strategy aligned with corporate goals and client needs
Serve as the primary regulatory expert and advisor to senior management and project teams
Lead and mentor the Regulatory Affairs team
Build and maintain relationships with global regulatory agencies and industry associations
Oversee preparation, review, and submission of regulatory documents including INDs, NDAs, BLAs, ANDAs, IMPDs, CTAs, and other filings
Ensure regulatory compliance in all clinical trials
Develop and maintain global regulatory intelligence
Support clients with regulatory strategy, gap analysis, and submission planning
Establish and oversee systems for document management, tracking, and reporting of regulatory submissions
Partner with Business Development and Project Management teams to provide regulatory input during proposal development and client meetings

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

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
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

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
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Pharmacovigilance Project Manager

PrimeVigilance

Location:
United Kingdom , Guildford

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 11, 2025

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