Drug Safety Associate Job at iconplc (Seoul)

Pharmacovigilance Associate

The Pharmacovigilance Associate position with PrimeVigilance offers an opportuni...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

Life Science / Biomedical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science)
Time management, delegation, organization, multitasking skills, and good attention to detail
Strong interpersonal and communication skills
Advanced English skills, both verbal and written, at least B2
Advanced knowledge of MS Office

Job Responsibility

Processing of Individual Case Safety Reports in accordance with applicable regulations, PrimeVigilance procedures and client specific requirements and timelines
Performing ICSR follow up
Product Quality Complaint handling and interaction with Quality Assurance
MedDRA and WHO coding
Interacting with other departments (Quality / Medical Information) as required

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

Production Associate - Fill

The Production Associate contributes to saving and sustaining lives by inspectin...

Location

United States , Marion

Salary:

17.88 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must be at least 18 years of age
Must have basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Must be able to perform basic mathematics
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
CRC (Career Readiness Certification) at the Silver level, preferred
Requires continuous grasping, pushing/pulling up to 12 pounds for up to 25 feet and reaching with hands and arms
Lifting on average up to 16 pounds to/from a height of up to 46 inches constantly throughout the shift
Carrying on average up to 10 pounds for 5 feet constantly throughout the shift

Job Responsibility

Over-pouch and seal the over-pouch, enclosing a bag containing solutions or premixed drugs, at a rate consistent with production needs
Inspect and ensure that the over-pouches, bags and their components meet quality standards
Perform scheduled quality checks using an assortment of gauges and a scale
Perform and document scheduled cleaning activities
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Sustain a clean and safe work area using 6S principles
Correct any over-pouch seal or packaging issues previously identified

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Fulltime

Production Associate, Fill

The Production Associate, Fill is an Hourly Non-Exempt position which contribute...

Location

United States , Marion

Salary:

18.40 USD / Hour

Baxter

Expiration Date

Until further notice

Requirements

Must have a High School Diploma or GED
Must be at least 18 years of age
CRC (Career Readiness Certification) at the Silver level, preferred
Possess or be able to obtain Inspector Certification
One year of manufacturing experience, preferred
Basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Ability to perform basic mathematics
Requires continuous grasping, pushing/pulling up to 40 pounds for a distance up to 50 feet and reaching with hands and arms up to 18 inches
Lifting and carrying on average up to 12 pounds frequently throughout the shift

Job Responsibility

Fill, assemble and plug flexible containers with solutions or premixed drugs at a rate consistent with production needs
Print labeling and bar code information on the flexible containers using a computerized printer
Maintain the printer by replacing printer foil, ribbon and by making minor adjustments
Supply the filling stations with printed bags and other supplies necessary to assemble the flexible container
Inspect and ensure that the printed bags and their components meet quality standards
Perform and document scheduled cleaning activities
Perform scheduled quality checks using an assortment of gauges and a scale
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
Sustain a clean and safe work area using 6S principles.

What we offer

Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Parttime

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Senior Data Scientist - Literature

Help bring science to life and join a leading pharmaceutical company to play a k...

Location

Switzerland , Basel

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in medicine, pharmacy, or natural sciences
Experience in information science, particularly within pharmacovigilance and drug development
Strong knowledge of medicine, drug development, and biomedical literature databases
Proficiency in scientific data evaluation, interpretation, and synthesis
Excellent written and verbal communication skills, with the ability to explain search strategies effectively
Expertise in classical text searching and familiarity with literature sources and databases
Ability to build strong working relationships in a cross-functional, international environment
Self-motivated, detail-oriented, and capable of prioritizing tasks effectively
Fluent in English, both written and spoken

Job Responsibility

Conduct ad-hoc literature searches in biomedical databases to identify adverse drug reactions and risks associated with medicinal products and devices
Develop, test, document, and maintain search profiles for various safety and efficacy reports, including DSURs, PBRERs, and MDIRs
Ensure timely and accurate delivery of search results while adhering to standard operating procedures
Collaborate with internal stakeholders to define search criteria and maintain effective relationships
Review and validate the plausibility of literature search results
Actively contribute to the Safety Literature Group by sharing knowledge and best practices
Create and deliver training materials on retrieval and reporting topics for team members and stakeholders
Proactively identify opportunities to improve processes, methods, and technologies
Address and escalate any issues related to literature searches as needed

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

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

Drug Safety Associate

iconplc

Location:
South Korea , Seoul

Category:
IT - Administration

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 14, 2026

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