Position Description
Title:Senior Manager of Drug Safety and Pharmacovigilance
Location: Edmonton, Alberta
Supervisor: Director of Drug Safety & Pharmacovigilance
Position overview
The SeniorManagerof Drug Safety & Pharmacovigilance (DS&P) is responsible for the medical, regulatory, and logistic management of the Serious Adverse Events (SAE) that occur in the CIRG trials
Key responsibilities
- Management of the SAE reports from a medical, regulatory, and administrative standpoint;
- Review of SAEs in the Safety Database (AERS); including event narratives
- Coding of AEs and SAEs in the Clinical Database and AERS
- Review of the SAEs for administrative and medical consistency; including requesting follow up and clarification information from the investigator
- Submission of SAE reports to the relevant parties
- Set up, implement, and maintain efficient SAE processing / dispatching logistics for the investigators, CRAs, sponsors and Health Authorities;
- Provide support to the Project Managers (Global Clinical Coordinators and Study Managers) and the CRAs to assure an appropriate monitoring and follow up of the SAE;
- Implement and maintain an efficient collaboration and communication process with the PV departments of the sponsors;
- Write the Pharmacovigilance report requested by the IDMC/DSMB;
- Contribute to the training of the members of a study team (including CRA, study coordinators, investigators) involved in the clinical research as far as Safety and Pharmacovigilance are concerned;
- Contribute to the Writing of SOPs, guidelines, and processes;
- Other Safety and Pharmacovigilance duties as required.
Education
-Scientific/medical background (Scientist or Pharmacist)
Experience
-At least 24 months of experience in Drug Safety and Pharmacovigilance including experience in clinical trials. Knowledge in oncology and experience in oncology trials are preferred.
-Experience with the Oracle Adverse Event Reporting System (AERS) is an asset
-Previous experience in supervision is an asset.
Skills
-Sense of prioritization and effective communication;
-Proficiency in team spirit, organization and planning;
-Excellent oral and written communication skills
-Outstandingidentification of problems and implementation of solutions;
-Able to work in a multi-cultural environment;
-Able to work in a rapid growing and evolving academic group;
-Excellentcomputer skills (Word, Excel, Power Point);
-Fluent English is required. Fluency in French would be an asset.
Relationships
This position reports to: Director of Drug Safety & Pharmacovigilance
He/she interacts with other CIRG teams (Project Management, CRA Management, Local CRAs, Data Management, QA), the investigators, the sponsors, and with the Independent Data Monitoring Committee in order to assure the safety of the patients involved in the CIRG trials.