- Job Title:
QPPV in Algeria
- Job type:
Full time
- Workplace type:
On site
- Job Reference:
- Location:
Algeria
- Reports To:
Head of pharmacovigilance
- Job Description:
-
- Manage and oversee the PV system in accordance with local legislation and company requirements which may include but not limited to: Business continuity, PV trainings, Local literature surveillance, PV agreements and obligations, risk management plan implementations, cross-functional, engagements. organized data collection programs, PV vendor
- Supplier oversight and management
- Manage/lead local pharmacovigilance activities and responsibilities as per local requirements
- Provide Pharmacovigilance expertise
- Collaborate with internal/external key partners, where applicable
- Support defining and implementing the local PV strategies as appropriate
- Ensure compliance to applicable local legislations, company standards and procedures
- Manage audit/inspection preparation and lead the audit/inspection
- Responsible for CAPA initiation and closure
- Communicate all potential safety issues immediately to the relevant stakeholders
- Performs local QPPV and/or local PV contact person activities and ensures out of office coverage for PV related matters in LOC. Ensures 24/7 availability to the local health authority, including timeous responses to any health authority requests
- Conduct PV training of all local PV employees, non-PV staff
- Support local literature surveillance in accordance with local and Global SOPs
- Support the development, implementation and utilization of local PV procedures at the LOC
- Support, where appropriate, local risk minimization activities conducted at the LOC
- Support PV activities related to Market Research (MR) and/or Patient Support Programs (PSPs) and non-interventional studies to ensure safety information is managed appropriately
- Ensure affiliate data in the local & global PSMF are up to date
- Keep abreast of local PV legislation
- Required Skills:
-
- 3-4years experience in pharmacovigilance and risk management within multinational organization is a must
- Strong knowledge of local and global regulations related to pharmacovigilance , attention to details and ability to handle confidential information, experience in audit preparation and conduct PV trainings
- Educational Background : Pharmacist, Physician
- Language/s: proficiency in English, French, Arabic
- Good knowledge of SOPs, ICH-GCP and local laws and regulations
- Application deadline: 2024-04-30
