Pharmacovigilance QA Manager Job at Randstad (Warszawa)

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Executive Director, Research & Development Quality Assurance

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United States , Cambridge; Bethesda

Salary:

224900.00 - 404600.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in a life science or related field
advanced degree preferred
15+ years of progressive experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety
10+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals
Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability
Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration
Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3)
Proven ability to collaborate and influence in a fast-paced, matrixed environment

Job Responsibility

Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio
Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda
Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
Embed risk-based quality management principles into study design, data generation, and vendor oversight practices
Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings
Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance
Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence
Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops
Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance
Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Job Responsibility

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Fulltime

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region
To ensure that RA processes are in place in his / her region

Job Responsibility

Local Complaint Coordinator activity
Product Surveillance activity for Medicinal Products and Medical Devices
Field Action execution
Supplier & Distributor Management
Implementation of Baxter Quality System in the region and audit management
NCR, CAPA and Change Management
Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available
To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.

Qa Releaser

This is a critical role supporting the safe, compliant manufacture and release o...

Location

United Kingdom , Thetford

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree or BTEC (or equivalent) in a Pharmaceutical or Science‑related discipline
Minimum 2 years’ experience in a GMP manufacturing environment
Experience in aseptic manufacture preferred but not essential
Background in Quality Assurance, Production, Validation or Microbiology is beneficial
Strong work ethic with flexibility to meet business needs
Uncompromising commitment to Quality
Excellent communication skills at all levels
A collaborative, supportive team player
Highly accurate with strong attention to detail
Analytical mindset with a desire to understand data and identify root causes

Job Responsibility

Ensure ongoing compliance of the Compounding Unit with cGMP, “Specials” requirements, and corporate policies
Provide QA oversight during aseptic manufacturing, supporting GMP decision‑making and addressing issues in real time
Attend Gemba activities to ensure facility and process compliance, identifying and implementing follow‑up actions
Maintain and implement EMS and continuous improvement principles
Inspect and release final products in line with company procedures
Execute timely and accurate batch and documentation reviews
Support product release targets and ensure deviations impacting release are fully assessed and dispositioned
Complete all Quality System and GMP commitments within agreed timelines
Prepare and support Annual Product Quality Reviews
Provide QA input into validation activities, planned/unplanned work, and change controls

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well‑Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qa Releaser

This is a critical role supporting the safe, compliant manufacture and release o...

Location

United Kingdom , Thetford

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree or BTEC (or equivalent) in a Pharmaceutical or Science‑related discipline
Minimum 2 years’ experience in a GMP manufacturing environment
Experience in aseptic manufacture preferred but not essential
Background in Quality Assurance, Production, Validation or Microbiology is beneficial
Strong work ethic with flexibility to meet business needs
Uncompromising commitment to Quality
Excellent communication skills at all levels
A collaborative, supportive team player
Highly accurate with strong attention to detail
Analytical mindset with a desire to understand data and identify root causes

Job Responsibility

Ensure ongoing compliance of the Compounding Unit with cGMP, “Specials” requirements, and corporate policies
Provide QA oversight during aseptic manufacturing, supporting GMP decision‑making and addressing issues in real time
Attend Gemba activities to ensure facility and process compliance, identifying and implementing follow‑up actions
Maintain and implement EMS and continuous improvement principles
Inspect and release final products in line with company procedures
Execute timely and accurate batch and documentation reviews
Support product release targets and ensure deviations impacting release are fully assessed and dispositioned
Complete all Quality System and GMP commitments within agreed timelines
Prepare and support Annual Product Quality Reviews
Provide QA input into validation activities, planned/unplanned work, and change controls

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well‑Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Pharmacovigilance Specialist

The Local Pharmacovigilance Specialist is responsible for the execution of tasks...

Location

Ukraine , Kyiv

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Professional education or University degree in Life Science preferred but not essential
Basic understanding/knowledge in the field of pharmacovigilance and medical information
Ability to prioritize and manage own time and tasks
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 point out issues and provide potential options for solution in the area of expertise
English business fluent

Job Responsibility

Data entry and quality control of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature
reporting of ICSRs to the competent authorities
Support in the generation, processing, documenting, and tracking of follow-up requests
Screening and documentation of scientific literature regarding safety relevant publications
Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
PSMF maintenance
Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for pharmacovigilance projects
Prepare for and participate in internal and external audits/inspections
Training new colleagues in relevant tasks

Fulltime

Senior Technology Quality Auditor

Technology Auditors possess significant authority and decision-making power with...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred.

Job Responsibility

Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines
Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
Travel internationally for audits, as required
Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
Review audit reports, responses and other program deliverable to ensure consistent high quality
Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities

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Pharmacovigilance QA Manager

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