Pharmacovigilance Project Manager Job at PrimeVigilance (Guildford)

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

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

Manager, Local Pharmacovigilance

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

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

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
Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Task and project management skills: Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
(Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Communication & presentation skills: 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

Senior Specialist Project Management Support

PharmaLex, part of Global Consulting Services (GCS) are seeking a Senior Special...

Location

Bulgaria , Sofia

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Professional degree in Sciences or Economics
Experienced user of the MS-office packages (excellent Excel knowledge), ERP-, project management- and database-systems
Basic understanding/knowledge in the field of pharmacovigilance
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 solutions
English business fluent & local language (as appropriate)

Job Responsibility

Program Management Support in the field of large volume outsourcing programs
Coordination, monitoring and preparation of project controlling and reporting
keeping an eye on the project’s overall budget
Informing the Customer Success Manager about potential discrepancies on budget
Support the tracking and reporting of set out targets (KPIs)
Initiation the control/ closing/ opening/ rebooking of times within work packages in PharmaLex Time tracking & Accounting System
Maintenance of program related projects in PharmaLex Time tracking & Accounting System from operative point of view
Supporting the onboarding / offboarding of resources (internal and external) as instructed by the Customer Success Manager
Compilation of regular check-point customer presentations
Keeping the overall reporting results transparent to the Customer Success Manager

Fulltime

Manager, Local Pharmacovigilance

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

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

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

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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