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Key Responsibilities and Required Skills for Drug Safety Associate

💰 $ - $

PharmacovigilanceDrug SafetyClinical ResearchHealthcareRegulatory Affairs

🎯 Role Definition

The Drug Safety Associate (also known as Pharmacovigilance Associate) is responsible for the timely, accurate intake, processing, and reporting of adverse events and safety data across clinical trials and post-marketing products. Working under established SOPs and ICH/GCP guidelines, the role ensures regulatory compliance for serious adverse event (SAE) case management, triage, medical assessment support, coding with MedDRA, and submission of expedited safety reports to health authorities. The Drug Safety Associate collaborates with clinical operations, medical, regulatory affairs, and quality teams to maintain the integrity of the global safety database and to support signal detection, aggregate safety reporting, and safety risk minimization activities.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator / Clinical Trial Assistant
  • Regulatory Affairs Assistant or Clinical Data Coordinator
  • Medical or Life Sciences graduate with internship in pharmacovigilance

Advancement To:

  • Senior Drug Safety Associate / PV Scientist
  • Drug Safety Case Processing Lead / PV Team Lead
  • Pharmacovigilance Specialist / Signal Detection Analyst
  • Safety Surveillance Manager / PV Manager

Lateral Moves:

  • Medical Information Specialist
  • Regulatory Affairs Associate
  • Quality Assurance Specialist (PV audits and oversight)

Core Responsibilities

Primary Functions

  • Receive, triage, and accurately document adverse event reports from investigators, patients, healthcare professionals, literature, and other sources into the global safety database in accordance with timelines defined by SOPs and regulatory guidance (e.g., expedited reporting requirements for SAEs/SUSARs).
  • Perform case intake and complete follow-up activities to obtain missing or clarifying information from reporting sites, treating physicians, or study teams to ensure case completeness and quality for regulatory reporting.
  • Conduct initial medical assessment of reported events in collaboration with clinicians or medical reviewers to determine seriousness, expectedness, causality, and regulatory reporting obligations.
  • Prepare, review, and submit expedited safety reports (e.g., CIOMS, MedWatch, e-RPS, E2B(R3) transmissions) to Health Authorities and relevant stakeholders within regulatory timelines (e.g., 7/15-day reporting windows).
  • Code adverse events, medical history, and concomitant medications using MedDRA and WHO Drug Dictionary (or other accepted coding dictionaries) ensuring consistency and accuracy for downstream safety analyses.
  • Enter, reconcile, and maintain high-quality safety data within global safety databases (e.g., Oracle Argus, ARISg, Veeva Vault Safety) and ensure proper linkage of related documents and source material.
  • Manage serious adverse event (SAE) expedited reporting workflows, ensuring complete case narratives, redactions for patient privacy, and adherence to company and regulatory reporting requirements.
  • Escalate potential signals, product quality issues, or safety trends to senior PV personnel and participate in triage and multi-disciplinary safety review meetings to support signal detection activities.
  • Support generation and validation of periodic aggregate safety reports including DSURs, PBRERs, PSURs, and periodic local safety update reports by compiling case listings and contributing to signal/aggregate sections as requested.
  • Execute literature screening and surveillance for adverse events, extract safety-relevant information, and enter relevant cases or references into the safety database and literature logs.
  • Maintain ICSR quality and perform case quality checks, reconciliation of source documents, line-listings, and audit-ready documentation to support internal and external inspections.
  • Support global safety reporting across multiple regions by managing country-specific expedited reporting requirements and transmission procedures to ensure compliance with local regulations.
  • Coordinate and document SUSAR reporting for clinical trials, ensuring unblinding procedures are followed where applicable and sponsor-investigator notifications are performed per protocol and regulatory requirements.
  • Collaborate with clinical operations and study teams to provide safety input into study documents, informed consent forms, protocol safety language, and investigator brochure updates.
  • Respond to safety-related inquiries from investigators, study coordinators, regulatory affairs, medical information, and pharmacovigilance colleagues, providing timely and accurate safety information consistent with approved labeling and SOPs.
  • Support case reconciliation across risk management systems, clinical databases, and the safety database to ensure consistent AE reporting and avoid duplicate or missed reporting.
  • Prepare and maintain accurate documentation for PV deliverables including case processing logs, training records, deviation reports, and corrective/preventive action follow-up as required by QA.
  • Participate in root cause analysis and corrective action plans for case processing issues, non-compliance, and audit findings; implement follow-up to demonstrate remediation and continuous improvement.
  • Contribute to development, review, and maintenance of pharmacovigilance SOPs, work instructions, and training materials to reflect current regulations and best practices.
  • Provide cross-functional support during inspections or audits by compiling case files, narratives, supporting documentation, and responding to PV-related queries from inspectors.
  • Participate in safety database upgrades, validation testing (UAT), and process improvement initiatives by documenting business requirements, executing test scripts, and validating outputs related to case processing and reporting.
  • Monitor safety signal tracking tools, support preliminary signal evaluation activities, and prepare initial summaries for pharmacovigilance scientists or safety management teams to facilitate timely risk assessment.

Secondary Functions

  • Support ad-hoc safety analyses, prepare line listings and summary tables for safety review meetings, and assist in preparing slide decks and briefing materials for safety committees.
  • Assist medical information and regulatory teams with compiling accurate, approved safety content for product labeling updates and health authority submissions.
  • Participate in cross-functional safety training sessions for clinical and commercial teams to raise awareness of expedited reporting obligations and safety best practices.
  • Contribute to vendor oversight activities by reviewing vendor SOPs, monitoring KPIs for case processing vendors, and assisting with vendor audit preparations and follow-up.
  • Support pharmacovigilance system master file (PSMF) updates and local PV system documentation to ensure completeness and readiness for inspections.
  • Maintain up-to-date awareness of global safety regulations, guidance (ICH, GVP), and industry trends, sharing relevant updates with the PV team.
  • Assist in the coordination of safety data exchange agreements (SDEAs) and ensure appropriate exchange of safety data between partners and third parties.
  • Participate in process mapping and continuous improvement initiatives to increase efficiency and reduce manual steps in case processing workflows.
  • Assist with preparation and reconciliation of safety budget and resource planning inputs for the pharmacovigilance department as requested.
  • Support translation coordination for non-English source documents and ensure accurate handling and storage of multi-lingual case narratives.

Required Skills & Competencies

Hard Skills (Technical)

  • Pharmacovigilance case processing and ICSR lifecycle management (intake, triage, entry, follow-up, reconciliation, reporting).
  • MedDRA coding proficiency (verbatim coding of adverse events) and experience with WHO Drug Dictionary or other medication coding dictionaries.
  • Experience with global safety databases such as Oracle Argus, ArisGlobal (ARISg), Veeva Vault Safety, or similar PV systems.
  • Knowledge of expedited reporting regulations and timelines for SAEs/SUSARs to regulatory authorities (FDA, EMA, PMDA and regional health authorities).
  • Familiarity with ICH Guidelines (e.g., ICH E2A, E2B, E2C, E2D), GVP modules, and Good Clinical Practice (ICH-GCP).
  • Ability to prepare and contribute to aggregate safety documents (DSUR, PBRER, PSUR) and periodic safety submissions.
  • Experience with literature screening methods, safety signal detection basics, and safety surveillance techniques.
  • Proficient in preparing CIOMS/MedWatch/CIOMS-style narratives, and E2B(R3) compliant case transmissions.
  • Working knowledge of clinical trial safety processes, unblinding procedures, and SUSAR management in clinical studies.
  • Competency in MS Office (Excel for line listings, pivot tables), plus familiarity with document management systems and electronic quality systems (eQMS).
  • Exposure to pharmacovigilance quality systems, audit processes, CAPA management, and inspection readiness.
  • Basic understanding of statistical concepts used in signal detection and safety summarization (descriptive statistics, rates).

Soft Skills

  • Strong written and verbal communication skills for clear, concise adverse event narratives and cross-functional collaboration.
  • Detail-oriented with a demonstrated ability to maintain high quality and accuracy under tight regulatory timelines.
  • Critical thinking and clinical judgment to support medical assessment and causality discussions with clinical reviewers.
  • Strong organizational skills and time management to prioritize multiple cases and meet expedited submission deadlines.
  • Team-player mindset with ability to collaborate across clinical, regulatory, medical, and quality teams.
  • Adaptability and willingness to learn evolving regulations, databases, and safety processes in a dynamic environment.
  • Problem-solving orientation to identify root causes of data or process issues and propose practical improvements.
  • Cultural sensitivity and ability to manage multi-lingual documentation and global safety reporting requirements.
  • Accountability and integrity in handling confidential patient data and compliance with privacy regulations (e.g., GDPR).
  • Proactive attitude for continuous process improvement and contribution to PV program maturity.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Science, public health, or a related field.

Preferred Education:

  • Bachelor’s or Master’s degree in Pharmacy, Nursing, Medicine, Pharmacology, or related pharmaceutical sciences.
  • Additional certification in pharmacovigilance or regulatory affairs is advantageous (e.g., DIA PV courses, PV certifications).

Relevant Fields of Study:

  • Pharmacy
  • Nursing
  • Medicine / Medical Sciences
  • Pharmacology / Toxicology
  • Biomedical Sciences
  • Public Health / Epidemiology

Experience Requirements

Typical Experience Range:

  • 1–4 years of direct pharmacovigilance or drug safety experience for a Drug Safety Associate role. Entry-level candidates with internships or clinical research experience may be considered for junior roles.

Preferred:

  • 2+ years case processing experience in a pharmaceutical, biotech, CRO, or PV vendor environment.
  • Demonstrated experience with at least one global safety database (Oracle Argus, ARISg, Veeva, etc.), MedDRA coding, and regulatory expedited reporting.
  • Experience supporting clinical trial safety (SUSAR/SAE reporting) and post-marketing safety surveillance is highly desirable.
  • Prior exposure to literature screening, aggregate reporting (DSUR/PBRER), and PV quality systems (audits, CAPA) preferred.
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