Asst I PSS at Fortrea

Manila, Metro Manila, Philippines -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

17 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Safety, Adverse Events, Data Entry, Patient Narratives, MedDRA Coding, Listedness Assessment, Query Generation, Database Reconciliation, Quality Management, Documentation Maintenance, Regulatory Compliance, Client Service, Teamwork, Health and Safety Compliance, Communication, Problem Solving

Industry

Biotechnology Research

Description

Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities: Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional units. Support compliance of operations with governing regulatory requirements. All other duties as needed or assigned. Qualifications (Minimum Required): 2 years clinical or community experience Must be a registered Nurse or Pharmacist Must be amenable to work in a Hybrid set-up in Greenhills, San Juan, Metro Manila Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Responsibilities

Assist with the overall Clinical Safety and PSS operations associated with products, including managing and processing adverse events. Ensure compliance with regulatory requirements and provide quality service to clients.