Job Title : Local Safety Manager
Job Description and Requirement Details
Qualification : Masters or Bachelors degree in Pharmacy or Masters degree in any life science field. Health Care Professional will also be preferred
Preferred experience :
Key Words : Pharmacovigilance.
Job Summary : This is a role that requires to maintain the local PV system in terms of structure and performance to ensure compliance with regulatory requirements and global procedures.
This role includes not only local PV activities but also communicate and collaborate with global PV functions and will directly report to the Head of global PV function in charge of local PV system management.
II. Key Responsibilities
Safety Reporting (ICSR)
Collect and report the Safety Information to Global Pharmacovigilance according to relevant SOPs.
Perform follow-up on Safety Reports, including Pregnancy cases, as per relevant SOPs / WPs.
Safety Reporting (Significant / Emerging Safety Issue)
Report the significant, emerging safety issues to the Health Authority as required.
Conduct local PV trainings for employees and vendors.
Paricipate in PV trainings organized by global PV.
Maintenance of Local PV SOP
Develop and maintain local PV SOP to ensure compliance with the requirements.
Submit the required Aggregate Reports (e.g., PSUR, PBRER, and / or DSUR) to the applicable local regulatory authorities, if required.
Risk Management Plan
Oversight of local Risk Management Plan (RMP), if required, including generation of local RMP documents, submission to the applicable health authorities, implementation of approved RMP model.
Local Literature Search
Identify Safety Information detected by local literature search and report it to global PV.
Interface with Other Functions
Safety information reconciliation with relevant team such as Product Quality Complaint and Medical Inquiries.
Work on PV-related CAPA management.
Maintain current knowledge of all local regulatory PV requirements in the Territory.
Manage responses to PV-related queries from health authorities.
Manage PV audit / inspection readiness and responses in collaboration with relevant global functions.
Interaction with Global PV
Escalate potential gaps or issues to global PV.
Participate into the activities organized by global PV.