DRUG SAFETY COORDINATOR[DSC] H/F

Job description

Entreprise:
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Poste et missions:
Main tasks:
- Monitoring pharmacovigilance operational business processes in line with the regulations controlling clinical trial drug safety and pharmacovigilance practices
- Liaising with DSPV collaborators; Drug safety Physician and Drug Safety Scientist identified for Safety Case management business process for the relevant projects.
- Maintains quality control of the handled safety data and liaising with QA department for the identified / recorded non-conformities and associated corrective and preventive action (NC/CAPA) the continual improvement of the Quality System
- Engaged in preparing project / study-specific forms/templates and Ensuring completion of necessary forms for the ongoing projects.
- Review the source documents to detect inconsistencies or obvious discrepancies at data entry.
- Enters project-related safety data into the safety database and sharepoint in accordance with sponsor agreed signed agreements and in line with company policy.
- Ensure accurate data entry of identified adverse event information and the timely processing and reporting of adverse events in alignment with regulatory requirements, ensuring reporting and following up on adverse events
- Manage coding as required in accordance with MedDRA and WHO Drug Dictionary
- Ensures current conventions are followed upon entering cases into the Safety database and narratives writing for assigned studies as applicable.
- Narrative summary development incorporating all relevant clinical trial and medical information
- Handling safety case submission to regulatory authorities, as required. Distributing expedited safety reports and periodic reports to sites, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory/Competent Authorities (RAs/CAs) according to project specific plans.
- Obtaining follow-up safety data/information from study sites as appropriate
- Assists with reconciliation of the safety and clinical databases to identify database discrepancies according to project-specific requirements.
- Performs case file creation, tracking, archiving and maintenance (paper and electronic) as indicated in the relevant procedures and working instruction.
- Records and tracks all adverse event fulfilling sponsor and authorities’ requirements, managing distribution of relevant mails and faxes
- Provide queries to the investigation sites; and follow-up on outstanding queries and requests.
- Participate in DSPV department and project status meetings and reports status to management as needed.
- Assists with generation/creation of presentation/training materials, as applicable.
- Monitor other team members for handled tasks as defined by head of DSPV such as team training coordination and team timesheet management, as appropriate. Escalates issues to management when needed
- Providing aggregate data (line listing and summary tabulation) as required, supporting safety signal management and the ongoing benefit-risk assessment.
- Produce regulatory report forms for distribution or filing
- Support administration and prepare expedited reporting of safety documents for regulatory authorities.
Profil:
- Requirements / Competency skills:
- Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations including Good Pharmacovigilance Practice (GVP), Good Clinical Practices (GCPs), ICH guidelines, and drug development cycle.
- Acquires basic understanding and maintains knowledge of ongoing projects and disease-related terminology.
- Familiar with coding dictionaries (MedDRA and WHO-DD)
- Ability to work independently across multiple projects and work collaboratively with other team members
- Organization skills and autonomy
- Meticulousness, eye for details and good interpersonal skills.
- Entrepreneurship and responsibility
- Proficiency in Microsoft Office Suite (Word, Excel, outlook and PowerPoint)
- Database and medical terminology preferred.
- Excellent oral and written communication skills.
- Strong interpersonal and customer service skills appropriate to a professional medical setting.
- Good organizational skills, detail oriented, and high degree of accuracy.
- Ability to handle multiple tasks and meet deadlines in a dynamic environment.
- Ability to work both independently and in a team environment.
- language skills:
- Fluent in reading, understanding, speaking and written English
- Other languages are plus point.
Education:
- BS/BA in life science (Biomedical / Pharmacological sciences)
Work experience:
- Relevant experience in the field of drug safety and pharmacovigilance business processes whether in pharmaceutical industry or clinical research organization (CRO).
- Pharmacovigilance in pre
- / post-authorisation product life cycle either in pharmaceuticals, Clinical research organizations or health authorities