Safety Specialist II

Precision For Medicine

Safety Specialist II at Precision for Medicine supporting clinical trial safety processes. Handling individual case safety reports and regulatory compliance in clinical environments.

Posted 7/6/2026full-timeRemote • 🇷🇸 SerbiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in processing and reporting Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements, utilizing the Oracle Argus Safety Database and adhering to Standard Operating Procedures (SOPs). Proficient in coding medical events and maintaining compliance with global safety regulations and guidelines.

Highest-signal resume keywords

Clinical Trial Drug Safety ExperienceOracle Argus Safety DatabaseMedDRA and WHODrug KnowledgeFDA Safety Regulations KnowledgeICH Guidelines Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Individual Case Safety Reports (ICSR) ProcessingData EntryEvent CodingCase Narrative DraftingData Reconciliation

Soft Skills

Attention to DetailEffective CommunicationProblem-Solving

Tools & Technologies

Argus Safety Database

Industry Keywords

PharmaCROGCPICH GuidelinesGlobal Safety RegulationsImmuno-OncologyAdvanced Therapy Medicinal Products

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.
Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans
Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
Enters data into Argus Safety Database
Code events, medical history, concomitant medications and tests
Draft case narratives
Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
Participates in audits/inspections as required
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
Attends Department meetings
Participates in project specific teleconferences/meetings as required
Other duties assigned by management

Requirements

What you’ll need

Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
Bachelor’s or first-level Degree in Pharmacy or Nursing preferred, but other Life Science, or other health-related field, or equivalent qualification. Immuno-oncology and Advanced Therapy Medicinal Products experience a plus.
Experience with Oracle Argus Safety Database
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations

Benefits

Comp & perks

Health insurance
Flexible work arrangements