Job Overview: Clinical Safety & Pharmacovigilance Associate (PSS Operations)
The Clinical Safety and/or Pharmacovigilance Support Services (PSS) Associate plays a crucial role in ensuring patient safety and compliance with global regulatory requirements. This position involves managing and processing adverse events (AEs) and serious adverse events (SAEs) from both clinical trials and post-marketing settings, ensuring timely and accurate reporting to clients and regulatory authorities.
The associate will also support project operations, maintain safety databases, and contribute to a culture of quality, safety, and compliance within the organization. This role demands close collaboration with internal teams, clients, and regulatory bodies while adhering to all applicable health, safety, and quality standards.
Key Responsibilities
1. Safety Reporting and Documentation
Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Maintain adverse event tracking systems and ensure accurate data entry.
Set up and manage project and central documentation files.
Log all incoming AE/SAE reports into tracking systems and forward them to the centralized mailbox.
Prepare and submit ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, and Investigators within study timelines.
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2. Adverse Event (AE) Processing
Enter safety data into AE tracking systems and write patient narratives.
Code AEs accurately using MedDRA terminology (for marketed products, if applicable).
Conduct listedness assessments against product labels (for marketed products).
Generate queries to collect missing or inconsistent data in consultation with medical staff.
Submit expedited SAE reports to stakeholders within agreed timelines.
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3. Quality and Compliance
Support peer review and quality checks of processed reports.
Assist with database reconciliation and maintenance of AE reporting requirements across countries.
Work within the Quality Management System (QMS) framework — adhering to SOPs, Work Instructions (WIs), and regulatory guidelines.
Prepare safety study files for archiving after project completion.
Ensure regulatory compliance with all governing safety standards.
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4. Team Support and Communication
Coordinate and schedule internal/external meetings and teleconferences.
Train and mentor new PSS Assistants or peers.
Build and maintain positive working relationships across functional units.
Provide administrative support to PSS personnel as needed.
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Qualifications
Education Level Minimum Experience Required
Non-Degree 1–2 years of Safety or relevant experience
Associate Degree 6 months–1 year of Safety or relevant experience
BS/BA 0–1 year of Safety or relevant experience
MS/MA 0–6 months of Safety or relevant experience
PharmD 0–6 months of Safety or relevant experience (Residency/Fellowship accepted as experience)
Preferred fields of study:
Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related disciplines.
Relevant experience includes:
Pharmaceutical, Biotechnology, or CRO roles in Medical Affairs, Clinical Data Management, Regulatory Affairs, or Quality Assurance.
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Skills & Competencies
Strong team player with collaborative attitude.
Excellent attention to detail and organizational skills.
Clear written and verbal communication in English and local language.
Logical reasoning, proofreading, and data handling ability.
Proficiency in MS Office and standard office equipment.
Ability to manage multiple tasks and meet tight deadlines.
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Work Environment
Primarily office-based or remote setting.
Must comply with the Health and Safety at Work Act (1974), COSHH Regulations (1989), and EC Directives (1992/3).
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Summary
This role is ideal for professionals looking to build a career in clinical safety, pharmacovigilance, or regulatory operations. By contributing to global patient safety, the Clinical Safety Associate ensures that every adverse event is managed with accuracy, timeliness, and care — protecting both patients and product integrity.
