Senior Safety Science Specialist

il y a 4 semaines

Lyon, Auvergne-Rhône-Alpes, France Pharmiweb Temps plein
Job Overview:

As a leading global contract research organization (CRO), Pharmiweb provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Pharmiweb is transforming drug and device development for partners and patients across the globe.

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 setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and 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 cost-effective manner. He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company's Health & Safety Manual.

Key Responsibilities:

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
  • Data entry of safety data onto adverse event database(s) and tracking systems.
  • Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
  • Write patient narratives and code adverse events accurately using MedDRA.
  • Determine listedness against appropriate label (for Marketed products, if applicable).
  • Identifies clinically significant information missing from the reports and ensures its collection and follow-up.
  • Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.
  • Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Pharmiweb project personnel, if required, within study specified timelines.
  • Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Pharmiweb project personnel, if required & as agreed with client during study set-up, within study specified timelines.


Perform Database reconciliation with Data Management team or sponsor/client as needed.

Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to:
  • Maintenance of adverse event tracking systems
  • Set-up and maintenance of project files and central files for documentation
  • Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Pharmiweb project personnel, as required, within study specified timelines.


Maintain a strong understanding of Pharmiweb's safety database conventions or client specific database conventions, as appropriate.

Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.

Begin participating in signal detection and trend & pattern recognition activities, as appropriate.

Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.

Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.

Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting

Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.

Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency.

Participate in Pharmiweb project team and client meetings, as appropriate.

Prepare and support coordination of safety study files for archiving at completion of projects.

Contribute to root cause analysis, including the CAPA plan development & implementation.

Support Audits and/or inspections preparation

Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees.

All other duties as needed or assigned.

Requirements:

High degree of accuracy with attention to detail.

Functions as a team player.

Good Communication and presentation skills.

Good written and verbal communication skills.

Knowledge of medical and drug terminology desirable.

Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.

Familiarity with ICH Guidelines.

Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.

Ability to work independently with minimal supervision.

Good keyboard skills, preferably with knowledge of MS office and Windows

Pharmiweb is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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