Senior Pharmacovigilance Officer Job at Theramex (Warsaw)

Regional Pharmacovigilance Senior Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

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

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

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

Senior Pharmacovigilance Associate

We are currently seeking a Senior Pharmacovigilance Associate to join our divers...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
High level of English proficiency
Based on Brazil - 100% remote position
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
Ability to work independently and manage multiple priorities in a fast-paced environment
Commitment to maintaining confidentiality and handling sensitive patient information with discretion

Job Responsibility

Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

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

Fulltime

Pharmacovigilance (PV) Officer

As a Pharmacovigilance (PV) Officer, you will play a key role within our Global ...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences
Minimum of 2 years’ experience in Case Processing and/or Drug Safety/Pharmacovigilance, with solid knowledge of global PV regulations
Detail‑oriented, organised, confident with medical terminology
Able to communicate effectively in English (written and spoken)
Experienced in using safety databases
Familiar with EudraVigilance (advantage)
Can multitask, manage projects, work independently as well as collaboratively
Eligible to work in Poland

Job Responsibility

Performing full and accurate case processing, including triage, MedDRA coding, seriousness assessment, narrative writing, and data entry into the global safety database in line with SOPs and regulatory requirements
Managing ICSR follow-ups and submitting ICSRs to various Health Authorities
Conducting AE/SAE reconciliation
Performing global literature reviews using tools such as Embase and MLM service
Handling EudraVigilance activities, including downloading and submitting ICSRs
Supporting the maintenance and use of the global safety database
Contributing to signal detection and risk management activities under guidance from senior team members and PV Physicians
Supporting development of PV and Regulatory documents (e.g., PSURs, RMP, RSI, HA responses) as required
Contributing to the preparation of the Theramex PSMF
Participating in PV audits and inspections

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

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

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expert knowledge of drug safety regulations and pharmacovigilance processes
Strong analytical and problem-solving abilities
Excellent communication and presentation skills
Superior organizational and time management capabilities
Proficiency with pharmacovigilance systems and databases
Proven experience in safety case management and regulatory reporting
Proficiency with safety databases and data analysis
Strong knowledge of ICH guidelines and regional requirements
Demonstrated mentoring abilities and process improvement skills
Experience in pharmaceutical or healthcare environments

Job Responsibility

Maintain expert-level knowledge of safety profiles, labeling, and global regulations
Lead development of project-specific procedures and workflows
Provide technical guidance to junior team members
Prepare for and participate in audits and inspections
Analyze metrics and drive continuous improvement
Collaborate with cross-functional teams on safety deliverables
Identify risks and recommend mitigation strategies
Ensure compliant documentation and archiving
Lead project management including safety procedure development and database setup
Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

New

Manager

We are looking for an organized and proactive Manager or Supervisor who will han...

Location

United States , Aiea

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

At least 2 years of experience in office administration, with added value from backgrounds in human resources, healthcare administration, or practice operations
Demonstrated ability to develop or manage policies, forms, procedures, documentation, or training materials
Strong organizational skills with the ability to handle multiple priorities independently and with a high level of accuracy
Clear written and verbal communication skills paired with a detail-oriented and service-oriented approach
Working knowledge of Google Workspace, including Docs, Sheets, and Drive
Experience supporting onboarding, employee documentation, compliance practices, or staff relations is preferred
Familiarity with medical or healthcare office workflows, billing processes, scheduling, or patient-facing operations is preferred
Previous experience training, mentoring, or supervising team members is preferred

Job Responsibility

Create and update internal HR documents, operational procedures, employee forms, and standard workflows to support consistency and compliance
Help maintain onboarding resources, handbook content, and staff training materials while keeping personnel files and training records accurate and secure
Build efficient office processes, track follow-up items, and support scheduling and administrative coordination across daily operations
Guide and support front desk team members through coaching, training, and quality oversight to promote excellent service and dependable execution
Monitor patient-facing administrative activities to ensure smooth arrival and departure experiences, and step in to assist front or back office coverage when needed
Support billing-related tasks such as insurance coordination, payment processing, and workflow improvements that strengthen revenue cycle operations
Assist with resolving issues involving payment tools, practice software, and vendor-supported systems to improve reliability and efficiency
Prepare reports, maintain business records in Google Workspace, and provide general administrative support including supply and inventory coordination

What we offer

medical
vision
dental
life and disability insurance
401(k) plan
free online training

New

Ao3 Administration Officer

Randstad are proud to currently be partnering with a large State Government Depa...

Location

Australia , Brisbane

Salary:

51.12 AUD / Hour

Randstad

Expiration Date

July 30, 2026

Requirements

Experience working effectively within a collaborative team environment
extremely high level of attention to detail and strong critical thinking skills
ability to use judgment and problem-solving skills under minimal supervision to manage competing priorities
knowledge of ArcGIS or other GIS software is highly regarded
analytical skills, the ability to interpret, review, edit, and collate numerical and written system data
excellent communication and customer service skills for engaging with stakeholders and the public
reliable, adaptable, and capable of managing confidential and sensitive departmental information
a current unrestricted 'C' class drivers’ licence
practical experience or qualifications in a related field will be favourably regarded

Job Responsibility

Providing timely and accurate administrative support, including completing internal quality assurance measures and delivering documentation
utilising ArcGIS and other systems/applications to produce outputs for aerial and ground jobs, including generating maps and related deliverables
monitoring and editing data for accuracy, maintaining electronic and hard-copy records, and raising data issues to ensure data integrity
using judgment and problem-solving skills when undertaking allocated tasks and non-routine requests to meet tight timeframes
exporting, reviewing, collating, and ordering data reports to be escalated to management for decision-making purposes
performing administrative support for treatment or surveillance activities, including generating appointments and bookings
providing high-quality customer service by responding to enquiries and accurately recording details on relevant databases
supporting the team by providing mentoring and training to new or inexperienced staff
participating in user acceptance testing, troubleshooting, and providing feedback for system upgrades
participating in the continual improvement of operational processes and identifying procedural inconsistencies

What we offer

Competitive hourly rate + super
Primary Berrinba location, transitioning to excellent hybrid options (up to 2 days working from home or utilising secondary depots across Ipswich, Logan, Moreton Bay, Brisbane, or the Gold Coast) after an initial 3-month training period
learn specialist skills and knowledge in GIS mapping software and large-scale government program operations
discounts at retailers like David Jones, Myer & JB HiFi, Rebel Sport, Woolworths, Hoyts cinemas and many more
a free Employee Assistance Program
access to your payslips at the click of a button via our MyRandstad App
a weekly pay cycle

Fulltime

New

Pharmacist - Full Time

We're building a world of health around every individual — shaping a more connec...

Location

United States , Stillwater

Salary:

60.00 - 73.00 USD / Hour

CVS Health

Expiration Date

September 30, 2026

Requirements

Bachelor of Science in Pharmacy or Pharm. D. degree
Active Pharmacy License in the state in which you are employed
Not on the DEA Excluded Parties List
Immunization Certification through an accredited organization (e.g., APhA)
No pending felony charges or convictions for criminal offenses involving controlled substances

Job Responsibility

Supporting the Pharmacy Manager in leading and directing Pharmacy Technician Support Staff
Accountable for supporting the management, oversight and operation of all aspects within your pharmacy including Patient Safety
Pharmacy Professional Practice
Regulatory Requirements
Quality Assurance
Customer Service
Personnel Management
Inventory Management
Financial Profitability
Loss Prevention

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs
Eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range

Fulltime

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Senior Pharmacovigilance Officer

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