Data Officer (Pharmacovigilance) Job at Product Life Group

Pharmacovigilance Assistant

We are currently seeking an Administrative Assistant to join our diverse and dyn...

Location

Poland; Bulgaria , Warsaw; Sofia

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry)
Basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential
Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently
Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting
Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols
Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint)
Fluent in written and verbal English
Ability to work effectively independently and within a team environment and across global teams

Job Responsibility

Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes
Provide administrative support to project teams as required
Distribute reports to Sponsors, sites, and applicable ICON personnel
Coordinate setup of required systems and mailboxes during study startup
File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF
Maintain data entry for safety event and miscellaneous tracking logs for all current projects
Assist with organization and planning of meetings
Daily entry into, and maintenance of, appropriate tracking systems
Maintain project training records for all assigned project team members
Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Data Officer

The Data Officer’s job is to guarantee the optimised management of vigilance dat...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

BPharm / MPharm
1-3 years of experience in pharmacovigilance
Management of vigilance data
Management of generic or client specific email boxes
Initial registration of vigilance cases into internal tracking tool
Duplicate search in the safety database (Client or PLG)
Initial triage assessment and data entry, MedDRA, narrative writing of vigilance cases into the client safety database after checking for duplicates
Be able to identify the seriousness of the case with or without the support of medically qualified personnel and using IME list where applicable and assessment of submission requirements
Preparation of initial email (in the context of follow- up request), requests for clarification and acknowledgements for the follow up of vigilance cases
Case closure

Job Responsibility

Guarantee the optimised management of vigilance data, both in terms of safety, administration, including traceability, in terms of the integration of this data into the various tools available (authorities, customer tools, internal tools)
Carry out the initial use of this data via ad hoc extractions in accordance with the objectives defined upstream
Contribute to the proper organisation of his/her Line Of Business
Database extraction of data for the calculation of KPIs
Preparation of activity reports for clients and activity monitoring for the calculation of quality / performance indicators
Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines
Provision of weekly/monthly/quarterly/yearly reports and activity monitoring for transmission to clients
Participation in audits to present the activity
Manage the processes related to the division’s activities and to ensure their proper implementation within the division

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

Regulatory/pharmacovigilance manager

This professional performs precise tasks aimed at checking legislation and drug ...

Location

Salary:

Not provided

Polifarma SpA

Expiration Date

Until further notice

Requirements

Graduate in medicine and surgery or in pharmacy, chemistry and pharmaceutical technology, biology or chemistry
Knowledge of clinical trials and quality systems
Previous experience in the post
Knowledge of national and EU legislation in the field of chemical products
Ability to archive and register documents
Ability to use data archiving software
Ability to produce information on regulatory aspects in the chemical field
Ability to apply techniques for drafting informative reports
Ability to complete paperwork for manufacturing products or apply administrative procedures for issuing permits, disclaimers and authorisations.

Job Responsibility

Ensure that all information concerning the safety of products after they have obtained marketing authorisation are brought quickly to the attention of health personnel
Draft the Periodic Safety Updated Reports (PSURs) and forward reports of suspected serious adverse and unexpected reactions to the national pharmacovigilance system
Notify the Pharmacovigilance Office of the Ministry of Health of any initiative adopted by other countries for safety reasons
Disseminate information notices and safety updates to prescribers
Maintain the MA and new registrations, even extra-EU
Activities linked to pharmacovigilance (collection of reports, any insights, database entries, follow-up)
Archiving and registering documents
Produce information on regulatory aspects in the chemical field
Apply techniques for drafting informative reports
Complete the paperwork for manufacturing products or apply the administrative procedures for issuing permits, disclaimers and authorisations.

Senior/Principal CSV Consultant

PLG is seeking a highly skilled Senior/Principal CSV Consultant to lead and supp...

Location

United States

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher in a relevant field (e.g., Life Sciences, IT, Quality)
2–5 years of experience in Computerized System Validation (CSV), Data Integrity (DI), or IT Quality within a regulated life sciences environment
Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11, and other applicable regulations
Hands-on experience authoring and executing validation deliverables, including URS, FS, IQ, OQ, PQ
Hands-on experience with risk-based validation approaches, such as GAMP 5 and ASTM E2500
Experience with validation of systems such as LIMS, CTMS, ERP, or eQMS platforms
Familiarity with systems across clinical, manufacturing, laboratory, supply chain, and pharmacovigilance environments
Experience with eValidation tools and digital quality platforms
Familiarity with IT infrastructure qualification (e.g., cloud, SaaS, hosting environments)
Exposure to lifecycle risk management, supplier assessment, and periodic review processes

Job Responsibility

Lead or support validation projects, including planning, execution, and documentation of CSV deliverables
Conduct system testing, defect tracking, and resolution activities
Review and approve validation deliverables authored by junior team members
Collaborate with clients to gather requirements, assess compliance gaps, and define validation strategies
Support digital quality initiatives, including deployment of eQMS and eValidation solutions
Contribute to audit and inspection readiness by ensuring documentation quality and regulatory alignment
Provide mentoring and guidance to Associate-level consultants
Oversee development of IT governance SOPs and quality documentation
Design and lead Data Integrity programs, including risk identification and mitigation
Conduct project, system, and vendor audits

Fulltime

Clinical Data Analyst

AB Science is hiring a Clinical Data Analyst based in Paris. Responsibilities co...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management
Knowledge of clinical development process
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Job Responsibility

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan
Ensure Clinical Data Management input to other relevant strategic study documents and vendor contracts
Detect important medical events
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database
Detect the forbidden concomitant treatments as per study protocol
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team
Archive documents in the clinical data management TMF

What we offer

Permanent position
Salary & package to define according skills and experience

Fulltime

New

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Sound knowledge of drug safety and the drug development process
Knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis and evaluation of safety data
Good presentation skills
Analytical and problem-solving skills
Clear understanding of the regulatory submission process
Proficient in database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills

Job Responsibility

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
Assist in development of project specific safety procedures, workflows and templates
Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
Delegate work as appropriate to Drug Safety Assistants
Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Data Officer (Pharmacovigilance)

Product Life Group

Location:

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 05, 2026

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