Pharmacovigilance (PV) Officer Job at Theramex (Warsaw)

Senior Pharmacovigilance Officer

As a Senior Pharmacovigilance Officer, you will be a key member of the Global Th...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

BSc or MSc in Life Sciences
Extensive experience in Drug Safety / Pharmacovigilance with strong knowledge of global PV regulations and GVP modules
Proven experience in authoring and reviewing safety documents, such as PSURs, RMPs, and responses to Health Authorities
Strong understanding of signal detection, risk management, and aggregate safety data review
Confidence using medical terminology, safety databases, and performing quality-driven case processing activities
Excellent written and verbal communication skills in English
High attention to detail, strong organisational ability, and excellent narrative writing skills
Demonstrated ability to multitask, manage projects, and work effectively in a changing environment
A collaborative mindset, with the ability to work independently in a self-directed manner
Experience mentoring or supporting junior colleagues (highly valued)

Job Responsibility

Performing signal detection and risk management activities under the guidance of PV Physicians and senior team members
Producing accurate aggregate data reviews and signal evaluation documents
Authoring and/or reviewing PV and Regulatory documents (e.g. PSURs, RMPs, RSI/SmPC/PIL, Health Authority responses) and contributing to study protocols
Performing and overseeing case processing activities
Monitoring PV compliance activities
Contributing to the preparation and maintenance of the Theramex Pharmacovigilance System Master File (PSMF)
Supporting the continuous enhancement of PV processes
Mentoring and training junior Pharmacovigilance colleagues
Delivering PV training to internal project teams and participating in external meetings
Supporting the negotiation and execution of Pharmacovigilance Agreements

Fulltime

Information and Documentation Officer

ProductLife Group is looking for an Information and Documentation Officer to joi...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Master or Bachelor of Pharmacy or life science graduate
1 to 3 years of experience in Pharmacovigilance or a Fresher with Pharmacovigilance knowledge
Good understanding of GVP Module VI
Training in PV
Understanding of literature writing or publishing
Understanding of PubMed and ADIS data base
Good oral/written communication in English
Advanced knowledge of Microsoft Office: Outlook, Teams, Excel, PowerPoint, Word, SharePoint
Good knowledge of pharmacology

Job Responsibility

Perform literature searches in international database and output preparation
Perform literature watch in local journals
Use the PubMed – ADIS international literature database, listing the cases found in the literature
Participate in client audits
Contribute to the implementation of the quality control system of the tasks performed and the follow up of the results
Receive, store and acknowledge receipt of documents sent by clients

Fulltime

Data Officer (Local Safety)

ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our d...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
Previous experience working to deadlines
Client communications
Knowledge of US and EU PV regulations
Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
Excellent organizational and interpersonal skills
Ability to work well within a team
Excellent time management skills

Job Responsibility

To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required
Management of the generic or client specific email boxes as appropriate
Registration, triage, assignment and coordination for the processing of vigilance cases
Follow-up requests with local reporters
Responding to queries from client and reporters
To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed
To participate in audits / inspections and resulting action plan

Fulltime

Customer Service Representative

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

Location

Sweden , Kista

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
3–5 years of customer service experience, preferably within a B2B and/or regulated healthcare environment
Fluent in Swedish and English, both written and spoken
Strong communication, interpersonal, and organizational skills
Demonstrated ability to operate standard office software and customer service systems
Ability to work independently with a high level of motivation, accountability, and attention to detail
Flexible and adaptable, with the ability to manage changing priorities and customer demands
Strong problem‑solving skills and the ability to handle challenging situations with professionalism and empathy
A collaborative team player who thrives in a dynamic environment and adapts well to change
Ability to build and maintain trusted relationships with customers and internal stakeholders

Job Responsibility

Receive, process, and manage customer orders via telephone, email and EDI
Serve as the primary contact for customer inquiries and requests, ensuring timely and professional responses
Log, investigate, and resolve customer issues related to orders, invoices, shipments, and deliveries
Maintain accurate customer records and ensure customer data is current and complete
Set up new customer accounts and maintain related documentation and system records
Prepare reports and provide business support information as required
Collaborate with cross‑functional teams on customer service initiatives and projects
Act as the primary customer contact for Sweden and the broader Nordic region (Denmark, Finland, Norway, Iceland)
Take full ownership of the (pre)‑order‑to‑cash process, including invoicing, dispute management, escalations, and emergency handling
Manage first‑line escalations and coordinate logistics activities as needed

What we offer

A challenging and rewarding role within a diverse, experienced, and supportive team
An independent position with opportunities to take ownership, influence processes, and make a meaningful impact
Professional development opportunities within the healthcare industry
Structured onboarding and internal training aligned with business needs and career aspirations
Stable employment within a well‑established, reputable global organization

Fulltime

Customer Service Representative

As a Customer Service Representative, you will join our Stockholm‑based Customer...

Location

Sweden , Kista

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
3–5 years of customer service experience, preferably within a B2B and/or regulated healthcare environment
Fluent in Swedish and English, both written and spoken
Strong communication, interpersonal, and organizational skills
Demonstrated ability to operate standard office software and customer service systems
Ability to work independently with a high level of motivation, accountability, and attention to detail
Flexible and adaptable, with the ability to manage changing priorities and customer demands
Strong problem-solving skills and the ability to handle challenging situations with professionalism and empathy
A collaborative team player who thrives in a dynamic environment and adapts well to change
Ability to build and maintain trusted relationships with customers and internal stakeholders

Job Responsibility

Receive, process, and manage customer orders via telephone, email and EDI
Serve as the primary contact for customer inquiries and requests, ensuring timely and professional responses
Log, investigate, and resolve customer issues related to orders, invoices, shipments, and deliveries
Maintain accurate customer records and ensure customer data is current and complete
Set up new customer accounts and maintain related documentation and system records
Prepare reports and provide business support information as required
Collaborate with cross-functional teams on customer service initiatives and projects
Act as the primary customer contact for Sweden and the broader Nordic region (Denmark, Finland, Norway, Iceland)
Take full ownership of the (pre)-order-to-cash process, including invoicing, dispute management, escalations, and emergency handling
Manage first-line escalations and coordinate logistics activities as needed

What we offer

A challenging and rewarding role within a diverse, experienced, and supportive team
An independent position with opportunities to take ownership, influence processes, and make a meaningful impact
Professional development opportunities within the healthcare industry
Structured onboarding and internal training aligned with business needs and career aspirations
Stable employment within a well-established, reputable global organization

Fulltime

Information and Documentation Officer

ProductLife Group is looking for an Information and Documentation Officer to joi...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Master or Bachelor of Pharmacy or life science graduate
1 to 3 years of experience in Pharmacovigilance or a Fresher with Pharmacovigilance knowledge
Good understanding of GVP Module VI
Training in PV
Understanding of literature writing or publishing

Job Responsibility

Perform literature searches in international database and output preparation
Perform literature watch in local journals
Use the PubMed – ADIS international literature database, listing the cases found in the literature
Participate in client audits
Contribute to the implementation of the quality control system of the tasks performed and the follow up of the results
Receive, store and acknowledge receipt of documents sent by clients

Fulltime

Drug Safety Analyst

We are seeking a Drug Safety Analyst to support global pharmacovigilance operati...

Location

United States , Los Angeles

Salary:

42.00 - 45.70 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Health Sciences, Life Sciences, or Information Technology
2+ years of pharmacovigilance experience
2+ years of safety database or data management experience
Strong experience with safety data analysis and reporting tools (Business Objects strongly preferred)
Hands-on experience with: Data extraction queries and reporting
Database querying for safety case analysis
Ensuring data integrity within safety systems
Experience supporting database configuration updates tied to regulatory submissions
Proficiency in Microsoft Office (Excel, PowerPoint, Visio, Word)
Experience in GMP environments and/or computer system validation (CSV) (essential)

Job Responsibility

Analyze and process safety data to support aggregate reports and regulatory submissions
Develop and execute data extraction queries for pharmacovigilance documentation
Perform database queries to identify interval and cumulative cases for periodic reports
Generate case listings for regulatory and business needs
Support signal detection and signal management activities
Maintain data consistency and integrity within the global safety database
Support database configuration updates, including: Regulatory submission rules
Product and study configurations
Partner with IT to support system validation, testing, and enhancements
Contribute to continuous system improvements and process optimization

What we offer

Flexible work arrangement (hybrid/remote potential)
Long-term contract with competitive pay
Opportunity to support global pharmacovigilance initiatives
High-impact role focused on data integrity, compliance, and patient safety

Fulltime

Manager QPPV Office

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

Location

Spain , Madrid

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Sciences (preferred but not essential)
Several years' experience and profound knowledge in the field of pharmacovigilance (global PV systems)
Expertise, experience and knowledge of relevant legislative and non-legislative guidelines and requirements on pharmacovigilance
Proved ability in leading, mentoring, managing and motivation of staff (for project teams)
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects 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)
ability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Prepare/maintain project-related documents
Compile the PSMFs (act as PSMF Coordinator) and ensure review/approval by the QPPV and timely submission to authorities, as needed
Quality check the PSMF prior to QPPV approval
Work on Pharmacovigilance projects for clients, based on experience and qualification
Includes negotiation of agreements, updates and terminations for all types of PVAs: SDEAs, PV Service Agreements, Quality Technical Agreements
Perform administrative tasks, as needed to support the QPPV and the PER PV GOV Practice Area
Act as Project lead (PL) for small projects (e.g. only QPPV/PSMF or PVA service in scope)
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks in line with their abilities, qualification and training, if required

Fulltime

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Pharmacovigilance (PV) Officer

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