
Clinical Lead
8 hours ago
About Our Organization
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service solutions.
The QPPV/Safety Manager plays a crucial role in the management of Drug Safety and works according to company policies, SOPs, and regulatory requirements.
Responsibilities:
- Hold QPPV responsibilities for some customers.
- Act as a Project Manager for Post marketing Safety-only projects.
- Write the safety parts in the PSUR/PBRER, RMP, and other safety documents.
- Conduct literature searches.
- Handle spontaneous adverse event reports from the market to ensure collection, assessment, and entry into the safety database in accordance with TFS/clients' SOPs and existing demands of the authorities.
- Review and approve processed cases and AE/SAE reconciliation.
- Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
- QC and approval of coding of adverse events, medical history, and concomitant medication.
- Electronic reporting to EudraVigilance.
- Contribute to plans/instructions and SOPs for post-approval surveillance.
- Update templates for safety handling in specific studies/projects according to relevant SOPs.
- Participate in relevant meetings and forward information to relevant department members.
- Provide internal support to other relevant departments.
- Involved in improvement projects with other relevant departments.
- Actively contribute to the organization and development of routines to enhance the work at TFS.
- Validation of computer applications specific for the department with respect to drug safety requirements.
- Stay informed and updated on laws, directives, and guidelines concerning pharmacovigilance and other safety issues.
- Educate and supervise new Drug Safety personnel.
- Participate in marketing activities.
Requirements:
- Bachelor's Degree, preferably in life science or nursing; or equivalent.
- Demonstrable experience working as a QPPV or Deputy QPPV.
- Able to work in a fast-paced environment with changing priorities.
- Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
- Understanding of Pharmacovigilance legislation.
- Ability to work independently as well as in a team matrix organization with little or no supervision.
- Excellent written and verbal communication skills.
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