Torchora
Back to Home

Key Responsibilities and Required Skills for Safety Data Management Specialist

💰 $ - $

PharmacovigilanceSafety Data ManagementHealthcareClinical SafetyLife SciencesData Analytics

🎯 Role Definition

A Safety Data Management Specialist is responsible for the accurate intake, processing, coding, quality control, reconciliation and regulatory reporting of individual safety case reports and aggregate safety data for marketed products and clinical programs. The role ensures compliance with global pharmacovigilance regulations (FDA, EMA, ICH), maintains safety databases, supports signal detection and risk management activities, and partners with clinical, regulatory, medical affairs and quality teams to protect patient safety and meet submission timelines.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator
  • Pharmacovigilance Associate / Drug Safety Associate I
  • Data Analyst with life‑sciences experience

Advancement To:

  • Senior Safety Data Management Specialist
  • Pharmacovigilance Lead / Safety Lead
  • Safety Database Administrator / PV Systems Lead

Lateral Moves:

  • Safety Case Processing Lead
  • Medical Information Specialist
  • Clinical Data Manager

Core Responsibilities

Primary Functions

  • Manage end‑to‑end adverse event case lifecycle: intake/triage, verification, MedDRA and WHO‑Drug coding, seriousness and expectedness assessment, causality documentation, follow‑up, and database closure in safety systems such as Argus, ARISg, Oracle Safety or Veeva Vault Safety.
  • Prepare, validate and submit expedited safety reports (e.g., 15‑day and 7‑day reports, IND Safety Reports, CIOMS) to global health authorities in accordance with timelines and ICH E2A/E2B(E2B(R3)) requirements.
  • Create and validate E2B(R3) XML transmissions and maintain accurate mapping between source data and E2B fields to ensure successful regulatory electronic submissions.
  • Perform case quality control (QC) reviews and data reconciliation between safety database records, clinical trial databases (CTMS/EDC), CRFs, and external vendor deliverables to ensure one version of truth for safety data.
  • Write clear, concise clinical narratives for serious adverse events (SAEs), SUSARs and deaths, combining medical facts with regulatory context suitable for regulatory submissions, CIOMS forms and safety committees.
  • Maintain safety database configuration and master data (e.g., MedDRA and WHODrug dictionary versions, code lists, user roles, business rules) and coordinate dictionary updates with change control and IT.
  • Conduct thorough literature and social media screening for safety signals, extract relevant safety information, and escalate potential signals to the signal management or PV medical review team.
  • Support periodic aggregate safety reporting requirements (PSURs/PBRERs, DSURs, PADERs) by producing line listings, summary tables, and contributing to safety narratives and benefit‑risk assessments.
  • Perform proactive signal detection and trend analysis using statistical tools (Empirica Signal, SAS, R, SQL) and create visualizations and dashboards to communicate safety trends to cross‑functional stakeholders.
  • Implement and maintain SOPs, process maps and work instructions for case processing, database administration, expedited reporting and quality controls to ensure GxP and PV system compliance.
  • Lead or support vendor oversight and vendor qualification for outsourced PV activities (case processing, coding, literature review), establishing KPIs, reviewing deliverables and driving corrective actions as needed.
  • Coordinate with clinical operations to ensure timely adverse event reconciliation from EDC/CTMS, including review of concomitant medication, event onset/resolution and subject disposition data to maintain data integrity.
  • Escalate and manage regulatory inspection and audit responses related to safety data, prepare root cause analyses, corrective and preventive actions (CAPAs), and track implementation for closed‑loop compliance.
  • Provide training and mentoring to junior case processors and cross‑functional colleagues on safety systems, MedDRA/WHODrug coding practice, and PV regulatory requirements to build team capability.
  • Design, maintain and deliver regular safety performance metrics and KPIs (e.g., case intake velocity, timeliness to report, quality scorecards) to executive leadership and regulatory teams.
  • Support safety database migrations, system upgrades and UAT testing by authoring functional specs, participating in validation activities, documenting defects and coordinating remediation with IT and vendors.
  • Evaluate and apply global regulatory requirements and company policies for special reporting scenarios (pregnancy, overdose, lack of efficacy, medication errors) and ensure accurate regulatory classification.
  • Prepare and support safety committee materials (Data Monitoring Committees, Pharmacovigilance Review Boards) including curated line listings, summaries and proposed risk minimization actions.
  • Maintain audit trails, track corrective actions and ensure accurate retention and archival of safety records in accordance with regulatory requirements and company record retention policies.
  • Collaborate with medical review and regulatory affairs to finalize causality assessments, expectedness determination and the medical/scientific interpretation of adverse event clusters.
  • Implement data privacy and security best practices when handling patient‑identifiable information and support compliance with relevant privacy legislation (e.g., GDPR, HIPAA) for safety datasets.
  • Lead root cause investigations for recurring data quality issues, recommend process improvements, automations or tooling (RPA, ETL pipelines) to reduce manual errors and accelerate case processing throughput.
  • Participate in cross‑functional project teams (clinical development, regulatory submissions, product safety updates) to ensure safety data inputs are timely, accurate and ready for submission or publication.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Expertise with safety databases and PV systems (Argus, ARISg, Oracle Safety, Veeva Vault Safety, ArisGlobal Safety, MedWatch portals).
  • Proficient in MedDRA coding and maintenance (term selection, version control) and WHODrug coding for concomitant medications.
  • Knowledge of ICH E2B(R3) electronic reporting standards and hands‑on experience generating E2B XML for regulatory submissions.
  • Experience preparing expedited reports, CIOMS, DSUR, PSUR/PBRER and PADER submissions in alignment with FDA/EMA timelines.
  • Strong SQL skills for extracting, querying and reconciling safety datasets; familiarity with ETL concepts and data mapping.
  • Experience with signal detection tools and statistical methods (Empirica Signal, SAS, R) and building safety dashboards (Tableau, Power BI, Spotfire).
  • Understanding of GxP, ICH‑GCP, pharmacovigilance regulations and global reporting requirements (FDA, EMA, PMDA).
  • Competence in case narrative writing, medical terminology, and collaborating with medical reviewers to document causality and clinical context.
  • Proficiency with Microsoft Excel (pivot tables, VLOOKUP/XLOOKUP, data cleansing) and experience automating repetitive PV tasks (RPA, macros).
  • Experience with quality management systems, SOP development, CAPA management and inspection readiness.

Soft Skills

  • Exceptional attention to detail and commitment to data quality in high‑volume environments.
  • Effective written and verbal communication skills for cross‑functional collaboration with medical, regulatory and clinical teams.
  • Strong problem solving and root cause analysis capabilities with a continuous improvement mindset.
  • Time and project management skills, able to prioritize tasks to meet tight regulatory deadlines.
  • Ability to mentor junior staff and run training sessions on PV systems and regulatory expectations.
  • Stakeholder management and vendor oversight experience; comfortable driving third‑party performance.
  • Critical thinking to interpret clinical data and escalate safety concerns appropriately.
  • Adaptability in fast‑paced, changing regulatory landscapes and system migrations.
  • Collaborative team player with the ability to work independently and take ownership of deliverables.
  • Ethical mindset and commitment to patient safety and data privacy/compliance.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Pharmacy, Nursing, Life Sciences, Pharmacology, Biotechnology, or related field.

Preferred Education:

  • Master's degree, PharmD, MD, or advanced degree in a life science, public health, or data science discipline.

Relevant Fields of Study:

  • Pharmacy
  • Nursing
  • Pharmacology / Toxicology
  • Life Sciences / Biology
  • Public Health / Epidemiology
  • Data Science / Biostatistics

Experience Requirements

Typical Experience Range: 3–7 years in pharmacovigilance, safety data management, clinical trial safety, or related roles.

Preferred:

  • 5+ years of experience managing individual case safety reports (ICSRs) and safety databases for pharmaceutical or biotech products.
  • Prior exposure to regulatory agency submissions, global reporting requirements, and PV system validation/migration projects.
  • Certifications or formal training in pharmacovigilance, MedDRA/WHODrug, or quality/QA in clinical research.
Explore More Careers