Drug Safety Specialist Job at Randstad (Berlin)

Safety Specialist II – Construction Management

Assists the Senior Construction Safety Project Manager to ensure a safe and heal...

Location

United States , Needham

Salary:

37.76 - 60.41 USD / Hour

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

A high school degree and 3 years of relatable experience and technical training in Life Safety is required
A Bachelor’s degree in Industrial Hygiene, Safety, Occupational Health, or a related scientific field and 1 yr is preferred
Communication skills to effectively deal with conflicting views or issues and mediate fair solutions
Very strong writing and math background for writing policy and compiling/collecting data
OSHA 500 Authorized Trainer, CIC-Certificate in Infection Control is required
Certifications in life safety, emergency response, hazardous materials management and safety management, is preferred

Job Responsibility

Conduct regular inspections of patient and non-patient areas helping to maintain a safe and compliant environment in the hospital
Work tactfully with client depts to ensure that non-compliant situations are addressed
Provide assistance and direction to Safety Specialist I
Assist Sr PM with routine admin tasks
Conduct routine reports, drills, and training for hospital staff
Support existing Construction Safety operations focused on construction permitting (PCRA), ICRA Assessments, contractor eForm submission reviews, Life Safety Compliance (ILSM Alerts), and Fire Stopping Policy compliance
Represent the Environmental Health & Safety (EHS) Department at committee meetings as assigned by the PM and present, take minutes and report back at the request of the PM
Respond to emergencies as a Safety On-Call Officer
Supports existing ICRA 2.0 compliance working with facilities project management, contractors and engineering department management personnel, including providing regular training on policy updates
Assist the Sr PM with high priority projects such as: hazardous drugs training and sampling, hazard assessments, exposure assessments, Environment of Care risks, and maintenance at Hospital satellite locations

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 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
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
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
Flexible work models where possible

Fulltime

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

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

Case Management – Specialist (Device Safety)

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Drug Safety or Life Sciences experience
Master’s degree and 7 years of Drug Safety or Life Sciences experience
Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience
Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
Bachelor’s Degree in a health-care subject area or scientific field
Previous experience with a corporate intake system or safety database
Ability to successfully manage workload to strict timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment

Job Responsibility

Support interactions with business partners (license partners) and vendors for all case intake and processing activities
Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Provide audit & external inspection support
Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases
Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Responsible for raise of device/combination product case related issues

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

New

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)

New

Safety & Pharmacovigilance Specialist

Piper Companies is seeking a Safety & Pharmacovigilance (S&P) Specialist to join...

Location

United States , Bethesda

Salary:

80000.00 - 90000.00 USD / Year

Piper Companies

Expiration Date

Until further notice

Requirements

Master’s/Medical Degree required
Minimum 2 years of experience in academic, pharmaceutical, or biotech industry
Strong knowledge of GCP and ICH guidelines
clinical trial experience essential
Familiarity with safety databases and MedDRA coding preferred
Experience leading clinical and cross-functional teams is a plus
Excellent oral, written, presentation, and computer skills

Job Responsibility

Ensure compliance with TRI SOPs, FDA, WHO, and global regulations for adverse event reporting
Develop and manage uniform, timely processing of adverse event reports
Provide medical evaluation of adverse event reports
Support clinical research activities including reporting, collecting, and sharing adverse event data
Maintain and update toxicity summary tables for investigational agents
Conduct literature searches related to drug safety and efficacy
Analyze and process adverse events
reconcile serious adverse events
Prepare IND safety reports for FDA submission and conduct safety data analysis
Provide clinical trial site support and manage safety communications

What we offer

CIGNA Medical, Dental, Vision
401K through ADP

Fulltime

New

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

Drug Safety Specialist

Randstad

Location:
Germany , Berlin

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 05, 2026

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