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Key Responsibilities and Required Skills for Safety Surveillance Associate

💰 $ - $

PharmacovigilanceDrug SafetyClinical ResearchHealthcareLife Sciences

🎯 Role Definition

As a Safety Surveillance Associate you will be responsible for end-to-end handling of individual case safety reports (ICSRs), timely regulatory reporting, routine safety surveillance activities including literature screening and aggregate report support, and cross‑functional collaboration to maintain compliance with global pharmacovigilance requirements. This role supports product safety signal detection and contributes to continuous improvement of safety processes and metrics.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Associate (CRA) transitioning into safety
  • Pharmacovigilance Analyst / Drug Safety Coordinator
  • Registered Nurse or Pharmacist with clinical trial safety exposure

Advancement To:

  • Senior Safety Surveillance Associate / Senior PV Specialist
  • Drug Safety Scientist / Safety Lead
  • Pharmacovigilance Manager / PV Team Lead

Lateral Moves:

  • Clinical Safety Scientist
  • Risk Management Associate
  • Medical Information / Medical Affairs roles

Core Responsibilities

Primary Functions

  • Receive, triage and accurately document spontaneous and solicited adverse event reports from multiple channels (healthcare professionals, patients, call centers, literature, clinical sites) ensuring timely entry into the safety database in accordance with company SOPs and regulatory timelines.
  • Perform complete ICSR case processing including data entry, case assessment, seriousness determination, expectedness, causality evaluation, narrative writing and quality checks to meet local and global expedited reporting requirements (e.g., 15-day/7-day reporting where applicable).
  • Code medical terms and concomitant medications using MedDRA and apply appropriate coding conventions to signs, symptoms and diagnoses to ensure standardized terminology across databases and reports.
  • Execute medical review of cases under supervision as required, flagging potential signals, duplicate reports, or special safety concerns and escalating to Safety Physicians or Safety Scientists for clinical assessment.
  • Prepare and submit expedited adverse event reports and aggregate periodic safety reports (e.g., CIOMS forms, SUSAR notifications, initial/follow-up reports) to health authorities and partners within regulatory timeframes using e-submission portals and company-approved processes.
  • Conduct continuous literature surveillance and screening of scientific journals, conference abstracts and safety alerts to identify relevant safety information and potential ICSRs for processing.
  • Review and reconcile safety data from clinical trial databases, CRO feeds, partner reports and medical information systems to ensure completeness and consistency of safety records.
  • Maintain the safety database (e.g., Argus/ArisGlobal/MedWatcher or equivalent) including case escalation flags, follow-up activities, and audit trails; ensure data integrity and timely resolution of open queries.
  • Support aggregate safety activities by contributing accurate case listings, line listings and safety datasets for PSURs/PBRERs, DSURs and internal safety reviews under the guidance of the lead safety scientist.
  • Participate in signal detection activities by preparing case summaries, contributing to signal packages, and liaising with epidemiology or biostatistics teams to provide case-level context for safety signals.
  • Execute follow-up activities to obtain missing information from reporters, investigators or external partners, document follow-up attempts, and close follow-ups in compliance with SOPs and timelines.
  • Collaborate with clinical teams to reconcile adverse events reported from clinical trials with ICH‑E2A/I and study safety reports and ensure consistent documentation across clinical and safety databases.
  • Support safety inspections and internal/external audits by preparing case documentation, responding to audit findings, and implementing corrective and preventive actions (CAPAs) related to case processing.
  • Train and mentor junior safety staff on ICSR processing, MedDRA coding, use of safety databases, and regulatory reporting requirements to build team capability and maintain high-quality outputs.
  • Monitor and report key pharmacovigilance metrics and operational KPIs (timeliness, quality, backlog, volume trends) and participate in regular team reviews to drive continuous improvement.
  • Apply company SOPs and regulatory guidance to classify reportability, determine expedited reporting obligations and ensure appropriate regulatory submissions for foreign and domestic cases.
  • Coordinate with vendors, CROs and external partners for case intake, data transfers and reconciliation activities to ensure compliance and data completeness across contracted relationships.
  • Draft clear, medically accurate case narratives and synopses to support regulatory submissions, safety committee reviews and signal assessments.
  • Support local safety/regulatory affairs teams with country-specific reporting requirements, compassionate use case management and special reporting (e.g., pregnancy exposure registries, overdose, medication errors).
  • Participate in cross-functional safety governance meetings (safety review committee, change control, risk management) and provide case-level input to support business decisions and risk minimization strategies.
  • Maintain current knowledge of global PV regulations, guidance documents and industry best practices; proactively share operational impacts and propose process improvements.
  • Identify, document and escalate complex or unusual safety cases (e.g., product quality complaints with AE association, fatalities, pediatric or pregnancy cases) to senior medical reviewers and regulatory leads promptly.
  • Ensure timely handling of vaccine or specialty product safety cases where applicable, following product-specific guidance and additional requirements for lot tracing or batch investigation.
  • Support implementation and validation activities for new safety systems or database upgrades, including user acceptance testing (UAT), test case execution and end-user training to ensure smooth transitions.

Secondary Functions

  • Assist in preparing materials for safety committees, advisory boards and cross-functional safety meetings, including slide decks and briefing documents.
  • Support periodic reconciliations between source systems (clinical, safety, medical information) and resolve discrepancies to ensure a single source of truth for safety data.
  • Participate in process improvement projects, SOP updates and automation initiatives to increase efficiency and reduce manual workload in case processing.
  • Serve as a point of contact for ad-hoc safety queries from internal stakeholders (clinical, regulatory, QA, supply chain) and provide timely case-level or process clarification.
  • Maintain training records, complete required PV training modules and contribute to the development of case processing job aids and quick reference guides.
  • Support vendor oversight activities by tracking vendor KPIs, reviewing vendor-generated cases for quality and participating in vendor governance calls.
  • Assist with reconciliation and submission readiness activities for regulatory inspections and prepare summaries of corrective actions implemented in response to audit findings.
  • Contribute to literature review strategy, including search term development, database queries and initial triage of potentially reportable cases.
  • Participate in safety data migration tasks, ensuring accurate mapping and validation of critical data fields during system transitions.
  • Help maintain and update local contact lists, reporting templates and escalation matrices to ensure rapid response in cases requiring urgent action.

Required Skills & Competencies

Hard Skills (Technical)

  • Hands-on experience with ICSR processing and safety case lifecycle management (intake to submission) in a regulated environment.
  • Proficient with safety databases such as Argus, ArisGlobal, Oracle, Veeva or similar PV systems; ability to enter, query and reconcile cases.
  • Strong MedDRA coding skills, including ability to select appropriate SOC/PT/LLT and perform coding quality checks.
  • Familiarity with global regulatory reporting requirements (ICH E2A/E2B(R3), FDA, EMA, CIOMS) and expedited reporting timelines.
  • Experience preparing CIOMS/CIOMS‑like reports, SUSARs, and expedited safety notifications.
  • Literature screening and case identification skills with experience using bibliographic databases (PubMed, Embase) and pharmacovigilance screening tools.
  • Ability to compose clear, medically accurate case narratives and to summarize complex clinical information.
  • Knowledge of safety aggregate reports (PSUR/PBRER, DSUR) data needs and contribution to dataset preparation.
  • Proficient in MS Office (Excel for line listings and reconciliations, Word for narratives, PowerPoint for safety presentations) and comfortable preparing standard operating reports.
  • Familiarity with eCTD/eSubmissions or electronic reporting portals and experience preparing documentation for regulatory submissions.
  • Basic database query and data reconciliation abilities; experience with SQL or data extract tools is a plus.
  • Understanding of GCP, pharmacovigilance SOPs, data privacy requirements (GDPR), and quality management systems.

Soft Skills

  • Exceptional attention to detail and a methodical approach to reviewing clinical and safety data.
  • Strong written and verbal communication skills for clear narratives and cross-functional interactions.
  • Critical thinking and clinical judgment to evaluate causality, seriousness and expectedness of adverse events.
  • Prioritization and time-management skills to handle high-volume intake with strict regulatory timelines.
  • Collaborative mindset with ability to work effectively with clinical, regulatory, medical affairs and quality teams.
  • Problem-solving orientation with a focus on process improvements and operational efficiency.
  • Adaptability in a changing regulatory and operational environment; comfortable handling ambiguity.
  • Accountability and ownership for case quality, compliance and timely completion of tasks.
  • Confidentiality and professional integrity when handling sensitive patient and safety information.
  • Training and mentoring aptitude to coach junior team members and provide constructive feedback.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or related health/science discipline.

Preferred Education:

  • Advanced degree (MSc, PharmD, RN, or equivalent) in a relevant field is preferred.

Relevant Fields of Study:

  • Pharmacy
  • Nursing
  • Medicine / Biomedical Sciences
  • Public Health / Epidemiology
  • Clinical Research

Experience Requirements

Typical Experience Range:

  • 1–3 years of direct pharmacovigilance, drug safety, clinical research or related healthcare experience.

Preferred:

  • 2–5 years of pharmacovigilance experience with proven ICSR processing, MedDRA coding and safety database exposure; experience in a pharmaceutical, biotech or large CRO environment preferred.
  • Demonstrated experience supporting regulatory submissions, literature surveillance and safety metrics reporting.
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