Patient Safety Specialist
Our Client, a global healthcare Company seeks to recruit a Patient Safety Specialist.
The Job holder will support management of Patient Safety operational processes at Country Organization in ensuring compliance with the Company’s global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the group, marketed and investigational products (drugs and devices).
Reports to: Patient Safety Group Manager
Roles and Responsibilities
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Company products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
- Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
- Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
- Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
- Management and maintenance of all relevant Patient Safety databases.
- Ensure that relevant local literature articles are screened as appropriate.
- Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
- Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
- Ensure support for and close-out of audits, corrective action plan, investigation and Health
- Authority inspections.
- Ensure training and oversight of staff, as applicable.
- Manage and maintain efficient Patient Safety filing and archive system.
- Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Re- search Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible for the trial
- Drive all Patient Oriented Programs pharmacovigilance related activities (case processing, submission to local Health Authority, conduct follow-ups, train stakeholders involved in POPs)
- And any other agreed tasks assigned by manager.
2 years experience in Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology.
- Excellent communications, interpersonal and negotiation skills
- Quality and focus oriented
- Proficiency in MS Office applications
Applicants who meet the requirements stated above should send their applications and detailed CVs with a day – time Telephone number to the email address: email@example.com with Patient Safety Specialist on the Subject line.