Senior Pharmacovigilance Specialist Job at Proclinical (Baar)

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 Specialist, Social Media PV CoE

As Safety Data Analyst, Social Media Monitoring, you will play a critical role i...

Location

Poland , Warsaw

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

University degree in Pharmacy/Medicine or other relevant life sciences discipline (Nursing, Experimental Medicine, Microbiology, Veterinary, Biotechnology, Physiotherapy, Medical Biology or similar)
Minimum 3 years’ experience in Pharmacovigilance, Drug Safety, or Quality roles
Experience with safety systems (e.g., MedDRA coding) preferred
Strong knowledge of ICSR requirements, product quality complaint handling, and PV regulatory standards (ICH, EMA, FDA)
Proficiency in English (knowledge of additional languages a plus)
Familiarity with social media monitoring tools and digital platforms is desirable
Proficiency in English (verbal and/or written) required due to global collaboration needs
Strong time management, problem solving, and critical thinking skills

Job Responsibility

Reviewing social media and social listening data records to detect and validate reportable safety events and product quality complaints
Performing quality checks to ensure accurate safety event classification, MedDRA coding, and appropriate product assignment
Identifying valid and invalid Individual Case Safety Reports (ICSRs) and Product Quality Complaints (PQCs) with precision and compliance
Sending timely safety and product quality notifications to relevant internal teams (Drug Safety and Product Quality)
Posting due diligence messages to reporters on monitored platforms (as permitted) and ensuring documentation of these interactions
Routing invalid ICSRs to internal dashboards to support broader signal detection activities
Supporting reconciliation processes to confirm data completeness and traceability
Escalating discrepancies, communication delays, or technical issues in data handling systems
Contributing to the generation of process KPIs and metrics
Assisting in inspection readiness, process improvement initiatives, and maintenance of monitoring tools as needed

What we offer

Best-in-class healthcare
Voluntary benefit programs
Access to fitness, mindfulness, and mental health support
Family building benefits including fertility, adoption, and surrogacy support
Generous paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

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 Manager Pharmacovigilance Operations

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree and 14 years of pharmaceutical, biotech or regulatory authority experience or relevant experience in a research and development setting
Health Care/Life Sciences Professional with minimum 12 years of relevant work experience including 5 years of experience in people management
Extensive people management experience
Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
Understands and interprets data/information and its practical application
Excellent English written/oral communication, and strong time and project management skills
strategic mindset, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations
Demonstrate knowledge of global aspects of pharmacovigilance
Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
Ability to effectively manage competing priorities and timelines

Job Responsibility

Supervision of a team of Literature Specialists responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS
Establish and maintain governance frameworks for literature review, search strategy management, quality and compliance oversight, systems and operational support
Ensure consistent achievement of internal/external SLA/TAT commitments
Oversee workflow management, mailbox operations, ancillary activities
Monitor and optimize queue volumes and ageing, productivity and utilization, vendor performance
Oversee quality framework including QC processes and error monitoring, CAPA management and closure, trend analysis and risk mitigation
May perform retrospective quality checks on the quality of the literature review performed by team
Business process owner for global literature review process and literature management systems
Drive initiatives to improve throughput and cycle time, optimize cost and resource utilization, reduce manual effort through automation
Lead cross-functional improvement programs

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.

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)

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

Fulltime

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