Phoenix Cr / is Hiring CDD
Phoenix Cr is looking for
Local Safety Responsible (LSR)
in Tunisia.
Requirements:
- Pharmacist
- 1-2 years experience in PV
- Must be located in Tunisia
- Has finished PV training
Job Description:
To establish and maintain the clients’ national Pharmacovigilance Sub-System File (PSSF) and summary PSSF
• To have an overview of medicinal product safety profiles and any emerging safety concerns, if possible
• To maintain awareness of PV regulatory requirements and developments
• To identify, collect and report Adverse Events (AE), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), Suspected Unexpected Serious Adverse Reactions (SUSARs) at the national level
• To ensure that the conduct of PV activities and submission of all PV-related documents, such as Individual Case Safety Reports (ICSRs), SUSARs, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) are in accordance with the legal requirements and the national Good Pharmacovigilance Practices (GVP)
• To provide input in response to emerging safety concerns at the national level (e.g. variations, urgent safety restrictions, communication to patients and healthcare professionals)
• To read and acknowledge all necessary company standard operating procedures (SOPs) and clients’ SOPs as required
• To maintain a local register of all incoming PV-related information and all correspondence in relation to PV activities with National Competent Authority (NCA) and clients based on the signed agreements
• To act as a single point of contact for the NCA on a 24-hour basis 7 days a week
• To handle spontaneous and clinical trial case reports
• To identify and report safety signals
• To interact with relevant clients, sub-contractors and service providers to collate information for PV matters when needed, and contribute to high level PV scientific activities being properly attended and guided
• To be involved in the review of key regulatory documents
• Other duties as needed or required
