Job Title: Assistant I, Patient Safety Solutions (PSS)
Location: Pune, India
Category: Clinical
Job ID: 254803
Assist with overall Clinical Safety and Patient Safety Solutions (PSS) operations, including the complete adverse event (AE) process for clinical trials and post-marketing settings. Ensure timely and accurate reporting of expedited safety events to clients and regulatory authorities. Deliver high-quality services while complying with all regulatory, legal, and company safety requirements.
Adverse Event Processing
Perform case intake and triage for incoming safety information or reports from spontaneous sources or clinical trials.
Assist with processing adverse events, including:
Data entry of safety data into AE tracking systems.
Writing patient narratives and coding adverse events using MedDRA (for marketed products, if applicable).
Assisting in listedness assessment against appropriate labels.
Generating queries and collecting missing or discrepant information in consultation with medical staff.
Support submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and internal project personnel.
Assist with processing and submission of expedited and periodic reports globally, prioritizing cases according to regulatory and study-specific timelines.
Data Management & Documentation
Assist in reconciliation of safety databases.
Maintain project and study-level documentation in accordance with regulatory and SOP requirements.
Support upload and archival of case, study, and project documentation as appropriate.
Quality & Compliance
Operate within the Quality Management System framework, adhering to SOPs and departmental Work Instructions (WIs).
Support compliance of PSS operations with governing regulatory requirements.
Assist in maintaining supporting files/documentation regarding AE reporting requirements in all countries.
Team Collaboration & Communication
Build and maintain positive PSS relationships across functional units.
Collaborate effectively with peers, senior staff, and cross-functional teams.
Perform additional duties as assigned by management.
Minimum Required
Education & Experience options:
Non-degree: 6 months – 1 year of Safety experience or relevant experience
Associate Degree: 0–6 months of Safety experience or relevant experience
BS/BA: 0–6 months of Safety experience or relevant experience
MS/MA or PharmD: 0 years of Safety experience or relevant experience
Relevant degrees: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
Safety experience: Processing AE/SAE reports, generating narratives and queries, using safety databases, regulatory submissions.
Relevant experience: Pharmaceutical, biotechnology, or CRO industry roles such as Medical Affairs, Clinical Data Entry, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance.
Skills & Competencies
High attention to detail and accuracy.
Team player with effective written and verbal communication skills.
Accurate mathematical and spelling abilities; aptitude for proofreading numerical data.
Proficiency in MS Office and Windows applications preferred.
Ability to operate standard office equipment.
Office or remote-based environment.
Compliance with Health and Safety regulations (Health and Safety at Work Act 1974, COSHH 1989, EC Directives 1992/3).
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