Drug Safety Associate Job at iconplc (Seoul)

Drug Safety Associate

At Pfizer, our Worldwide Safety colleagues are pivotal in bridging evidence-base...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Pharmacy or Medical
Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
Fluent in spoken and written English

Job Responsibility

Monitor the company's drug, biologics, and medical devices surveillance program
Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities
Make decisions within limited options to resolve problems, under the supervisor's direction
Work in a structured environment, following established procedures
Ensure work is regularly reviewed for technical judgment, completeness, and accuracy
Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams
Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and related activities
Determine the appropriate workflow for case processing by reviewing case criteria

Fulltime

Drug Safety Associate

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

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Prior experience or strong interest in clinical research
Knowledge of clinical trial processes, regulations, and guidelines
Excellent organizational and communication skills
Ability to work collaboratively in a fast-paced environment with attention to detail
1~2 years pharmacovigilance experience

Job Responsibility

개별 사례안전보고서 (수신된 ICSR추적, 회사 또는 고객 안전 DB에 입력, 쿼리 관리)
통합안전보고서 생성지원 (약물별 정기 보고 support)
클라이언트의 라이센스 파트너에게 안전 보고서 제출
약물감시 매뉴얼 개정 또는 제정 협업

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

Patient Safety Associate I (Drug Safety Associate I)

At Parexel, we’re dedicated to improving patient health worldwide. As a Patient ...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Foundational knowledge of drug safety regulations and pharmacovigilance processes
Ideal candidate has 3+ years experience in Drug Safety
2+ years experience in a post marketing
Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
Strong attention to detail, organizational skills, and problem-solving ability
Effective communication and willingness to work in a collaborative team environment
Proficiency with MS Office and ability to learn safety systems/databases
Preference for those with Veeva Safety experience
Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience

Job Responsibility

Processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
Conducting comprehensive literature searches and reviews to identify safety signals
Supporting signal detection and management activities
Tracking and monitoring regulatory information updates
Assisting in preparing and executing regulatory submissions
Contributing to the development of aggregate reports and study-specific safety documents
Managing Medical and Product Dictionary activities where applicable
Maintaining compliance through quality reviews of safety deliverables
Generating metrics and performance indicators for safety operations
Investigating and documenting late deliverable incidents

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

Manufacturing Associate, Drug Substance - Shift Position

As a Manufacturing Associate at our Harwell site, you will operate cutting-edge ...

Location

United Kingdom , Oxford

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

1+ years of experience in a GMP manufacturing environment
A university degree with a specialization in Pharmaceutical production technology or equivalent
Ability to collaborate fluidly with peers, leadership and cross-functional support groups
Excellent written, oral communication, and organizational skills
Ability to maintain attention to detail while executing multiple tasks with minimal supervision
Demonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless

Job Responsibility

Operate and monitor production equipment while adhering to cGMP, SOPs, and health and safety procedures
Maintain a clean, compliant, and safe work environment through strict adherence to gowning and housekeeping standards
Execute operations and maintain accurate manufacturing documentation for batch disposition
Perform routine equipment maintenance such as lubrication, filter changes, and mechanical checks using hand-tools
Troubleshoot digital and equipment-related issues rapidly and efficiently
Keep training records and operational logs up to date, ensuring full compliance
Work flexibly including off-hours or overtime to support manufacturing schedules
Take part in deviation investigations (RCA), CAPA tasks, and contribute to incident analyses
Collaborate closely with QA and other cross-functional teams to meet production KPIs

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

Patient Safety Associate

Deliver Excellence in Pharmacovigilance. Join Our Patient Safety Team as a Patie...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Health Science degree or equivalent
Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices
Good working knowledge of the regulatory requirements for managing and reporting adverse events in Philippines
Experience in clinical trial pharmacovigilance
Understanding of the applicable Australia, New Zealand and EU requirements
Highly developed service, communication, organisational and problem-solving skills
High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety)
Practical experience in SOP writing and document management

Job Responsibility

Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance
Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP)
Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures
Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria
Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance
Maintain the integrity of client safety data registered into the safety databases
Participate in internal and external audits
Perform literature surveillance and regulatory authority adverse event searches
Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements)

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory

Job Responsibility

Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature

Fulltime

Senior Associate Manufacturing, Drug Product

At Amgen, our mission—to serve patients—drives everything we do. As a Sr Associa...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 6 months of Manufacturing support experience OR Associate's degree and 2 years of Manufacturing support experience OR High school diploma / GED and 4 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen's electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

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Drug Safety Associate

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