Senior Pharmacovigilance Specialist Job at Proclinical (Baar)

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

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 Pharmacovigilance QA Specialist

We are seeking a highly experienced and detail-oriented Senior Pharmacovigilance...

Location

India , Chandigarh

Salary:

Not provided

Randstad

Expiration Date

July 05, 2026

Requirements

15 years of experience

Job Responsibility

Handling client audits and regulatory inspections
Management of quality issues/events/deviations and CAPAs
Performing RCAs and/or providing guidance to the staff in performing RCAs
Developing CAPA plans and/or providing guidance to the staff in developing and implementing CAPAs

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)

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 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 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

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Senior Pharmacovigilance Specialist

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