Fortrea M Pharma Jobs | Apply Now for Assistant I PSS Position
Are you looking for a hybrid opportunity in clinical safety and pharmacovigilance? Fortrea is hiring an Assistant I PSS in Pune, India. This role involves supporting the operations of Clinical Safety and Patient Safety Services (PSS), including handling adverse event reporting, compliance, and regulatory submissions. Join Fortrea’s global team and build your career in pharmaceutical safety while ensuring the highest standards of patient care.
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) specializing in clinical development, patient safety, and regulatory services. With a strong focus on innovation and compliance, Fortrea partners with pharmaceutical and biotechnology companies worldwide to bring safe, effective medicines to patients faster. Our diverse team of professionals is dedicated to advancing healthcare and creating meaningful career opportunities in the life sciences sector.
Job Details
- Job Title: Assistant I PSS
- Location: Pune (Hybrid)
- Job Type: Full-Time
- End Date: October 6, 2025
- Job Requisition ID: 254803
Job Overview
As an Assistant I PSS at Fortrea, you will support Clinical Safety and Patient Safety Services (PSS) operations. This includes managing the adverse events process, from clinical trials and post-marketing reports to regulatory submissions. You will be responsible for processing safety data, writing narratives, submitting reports to clients and regulatory agencies, and maintaining compliance with global standards.
Responsibilities
- Perform intake and triage of safety information from spontaneous sources or clinical trials.
- Assist in adverse event processing, including data entry, coding with MedDRA, and patient narratives.
- Conduct listedness assessments for marketed products.
- Generate queries and collect missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to clients, regulators, ethics committees, investigators, partners, and project teams within agreed timelines.
- Assist in expedited and periodic reporting to worldwide regulatory agencies.
- Support database reconciliation, documentation maintenance, and compliance with SOPs and WIs.
- Upload and archive study/project documentation as required.
- Build and maintain relationships across functional PSS units.
- Support compliance with global regulatory requirements.
- Perform additional duties as assigned.
Qualifications
- Non-Degree with 6 months – 1 year of Safety or relevant experience OR
- Associate Degree with 0–6 months of experience OR
- BS/BA with 0–6 months of experience OR
- MS/MA or PharmD with no prior experience (relevant field).
Preferred Backgrounds:
- Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
- Experience in pharmacovigilance, adverse event reporting, safety databases, or regulatory submissions.
- Relevant pharmaceutical, biotech, or CRO industry experience in Medical Affairs, Data Entry/Management, Monitoring, Regulatory Affairs, or Quality Assurance.
Skills & Competencies
- Strong attention to detail and organizational skills.
- Team player with excellent written and verbal communication.
- Proficiency with MS Office applications.
- Ability to handle and proofread numerical data accurately.
- Knowledge of safety processes and compliance standards.
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