CrawlJobs Logo
Theramex Logo Theramex · Pharmacy

Pharmacovigilance Manager

Poland, Warsaw · Job Posted March 19, 2026
Apply Position
Job Link Share

Job Description

As a Pharmacovigilance Manager within our Global Theramex Pharmacovigilance Team based in Warsaw HQ, you will provide strategic and operational pharmacovigilance expertise. This is a hands-on role with responsibility for safety surveillance, risk management, compliance, and authoring of key PV documents—especially aggregate safety reports.

Job Responsibility

  • Leading global aggregate safety reporting (planning, authoring, compliance)
  • Performing signal detection and risk management activities, providing clear recommendations and prioritising mitigation actions that add value for patients
  • Producing high‑quality aggregated data reviews and signal evaluations with clear conclusions and actions
  • Authoring and/or reviewing PV and regulatory documents (e.g., PSURs, RMPs, RSI, HA responses) and contributing to study protocols
  • Monitoring PV compliance (including ICSRs, aggregate reports, and safety variations)
  • Contributing to the preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Enhancing PV processes by reviewing and creating SOPs, Work Instructions, and procedural documents
  • Supporting case processing activities (data entry, coding, reconciliations, QC, reporting)
  • Mentoring and training junior colleagues, and delivering PV training to project teams or external partners
  • Participating in the negotiation and execution of PV agreements
  • Supporting and participating in PV audits and inspections as required
  • Performing any other responsibilities reasonably aligned with this role

Requirements

  • BSc or MSc in Life Sciences
  • Over 5 years’ experience in Drug Safety/Pharmacovigilance with strong understanding of global PV regulations and GVP modules
  • Proven track record in planning and authoring safety documents (e.g., PSURs, RMPs), with excellent medical writing skills and impeccable attention to detail
  • Experience leading strategy formulation, managing multiple projects, and navigating change
  • Confident with medical terminology, skilled in communication, highly organised, and comfortable working in rapidly evolving environments
  • Can work independently and as part of a team, prioritising effectively while managing diverse tasks
  • Fully proficient in English (spoken and written)

What we offer

  • A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
  • Support for your continued growth, learning, and development, with celebration of success and recognition of performance
  • Opportunities for driven and talented professionals who want to be part of our exciting journey
Theramex - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Pharmacovigilance Manager

8 matching positions

Observational Research Manager (Pharmacovigilance Epidemiology and Causal Inference / Obesity)

Observational Research, Manager (Pharmacovigilance Epidemiology and Causal Infer...
Location
Location
United States
Salary
Salary:
109087.30 - 147588.70 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • OR Master's degree and 3 years of scientific experience
  • OR Bachelor's Degree and 5 years of scientific experience
  • OR Associate's degree and 10 years of scientific experience
  • OR High school diploma / GED & 12 years of scientific experience
  • Doctorate in Epidemiology or other subject with high observational research content
  • Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting
  • Experience in applying causal inference frameworks such as target trial emulation or the causal roadmap to generate real-world evidence
  • Experience in research to support drug development
  • Experience working with secondary data systems, including administrative claims, EMR, registries
Job Responsibility
Job Responsibility
  • Design and execute studies based on causal inference frameworks to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, obtaining product registrations and label-expansions, meeting post-marketing requirements/commitments, and product differentiation
  • Identify opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
  • Influence cross-functional stakeholders as to the appropriate use and timing of non-interventional research to answer high-priority strategic business questions
  • Leverage real-world data and CfOR analytic approaches to inform high-value business decisions for multiple stakeholders
  • Contribute to the mission of CfOR, including progressing innovative epidemiological methods and analytical capabilities to support CfOR's leadership role within Amgen and industry
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
  • Fulltime
Read More
Arrow Right

Senior Manager Pharmacovigilance

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
Mexico , Mexico City
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in life sciences, pharmacy, or a related field
  • Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries
  • Strong understanding of regulatory requirements related to drug safety and reporting
  • Excellent analytical and problem-solving skills, with a focus on data-driven decision-making
  • Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders
Job Responsibility
Job Responsibility
  • Managing the pharmacovigilance team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards
  • Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices
  • Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans
  • Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials
  • Staying updated on industry regulations and best practices in pharmacovigilance to drive continuous improvement initiatives
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Read More
Arrow Right

Senior Manager Pharmacovigilance

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
Brazil , Sao Paulo
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in life sciences, pharmacy, or a related field
  • Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries
  • High level of English proficiency
  • Based on Brazil
  • Strong understanding of regulatory requirements related to drug safety and reporting
  • Excellent analytical and problem-solving skills, with a focus on data-driven decision-making
  • Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders
Job Responsibility
Job Responsibility
  • Managing the pharmacovigilance team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards
  • Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices
  • Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans
  • Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials
  • Staying updated on industry regulations and best practices in pharmacovigilance to drive continuous improvement initiatives
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Read More
Arrow Right

Pharmacovigilance QA Manager

Join our clients company as a Pharmacovigilance QA Manager, and work as a audito...
Location
Location
Poland , Warszawa
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
July 31, 2026
Flip Icon
Requirements
Requirements
  • 7 years of experience in clinical/Pharmacovigilance QA, or in the pharmacovigilance function
  • excellent knowledge of QA Standards, particularly Good Clinical and or GPvP Practice Guidelines and Regulations and other related areas as specific for the function (e.g. PV), as well as basic legal regulations
  • min. bachelor’s degree
  • fluent english
  • very good interpersonal and communication skills
  • ability to influence without authority
  • project management skills
  • excellent attention to details
  • flexibility and adaptability
  • current location in Poland
Job Responsibility
Job Responsibility
  • execution of regional, cross regional and/or global multiple audit programs
  • provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to: coaching on QA related processes, interpreting health authorities’ requirements and advising in their implementation across the organization
  • support the development, improvement and maintenance of the Company's Quality System by signalling root causes to non-conformances related to the system, by addressing observed gaps in the system
  • manage Quality Issues related to critical non-conformities, serious misconduct and potential fraud. Lead proper corrective and preventive actions identification and roll out and ensure follow up with effectiveness measures
  • develop, analyze and report relevant key performance indicator information
  • develop and manage interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to the company's business is being mitigated
  • Fulltime
Read More
Arrow Right

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...
Location
Location
Belgium , Mechelen
Salary
Salary:
Not provided
Cunesoft
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...
Location
Location
Belgium , Mechelen
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...
Location
Location
Belgium , Mechelen
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Regional Pharmacovigilance Senior Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
  • At least 7-12 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety
  • Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
  • Knowledge of the drug development process, GXP quality and compliance requirements
  • Good presentation skills with the ability to communicate complex issues clearly
  • Good planning and organizational skills with ability to manage competing priorities
  • Good oral and written communication skills
  • Ability to motivate, influence, and collaborate with multidisciplinary teams
  • Ability to work independently and in a global environment and have experience of this
  • Understanding of safety business processes and systems for the collections of adverse events
Job Responsibility
Job Responsibility
  • Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region
  • Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with client standards
  • Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions
  • Liaise between the global functions, the affiliates and Business Partners (overall Territories: EU, Canada, Australia, US, Japan and Brazil, MENA, South Korea, China, Singapore)
  • Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency
  • Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
  • Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
  • Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region
  • Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
  • Contribute to increase the visibility of the GPS team/function throughout
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Read More
Arrow Right