Local Safety Officer Saudi Arabia

5 months ago

Riyadh, Saudi Arabia CSL Behring Full time

**Responsibilities**:
The Local Safety Officer is responsible for the Pharmacovigilance System(s) in Saudi Arabia. LSO holds responsibility for fulfillment of local PV regulations and obligations following international requirements and CSLB processes under the guidance of GCSP Regions and in collaboration with contracted 3rd parties.
- Regulatory responsibility for pharmacovigilance (PV) and clinical safety (as applicable) related activities. Implement risk minimization requirements, handling of individual case safety reports (ICSRs), processing of all other safety information, and fulfilling territory specific PV regulatory requirements all fall under this responsibility (The LSO act as the national QPPV for Saudi Arabia).
- Primary contact person for GCSP and liaising between GCSP and multiple local team members regarding PV and safety risk management issues, e.g., Competent Regulatory Authorities, Commercial Operations, Quality Assurance (QA), and Partner Companies
- Escalate to GCSP of any new safety and PV related regulatory issue concerning CSL Products.
- Performing surveillance activities for any new potential safety information e.g. similar AEs reported in the country or multiple cases for one batch received in a short timeframe and escalate observing procedure.
- Overview of CSL Behring pharmacovigilance system described in Pharmacovigilance System Master File (PSMF) and other pharmacovigilance systems as described in Pharmacovigilance Subsystem Files (PSSF) for Saudi Arabia
- Maintain local compliance with GCSP related quality process and standards, including the development of local PV procedural documentation relevant to the applicable Territory.

**Reporting Relationships**:
You will report to: Scientific Office Manager for CSL Behring in Saudi Arabia

You will have a dotted line to Director, GCSP Regions Lead for ECI

Role and Responsibilities
- Develop and implement Local PV System including documented local PV procedures observing GCSP procedures and the local document management system. This includes a local process for handling out-of-hours pharmacovigilance enquiries.
- Responsible for Individual Case Safety Reports (ICSRs) handling, including receipt, translation, reporting, tracking, follow-up, document archiving, reconciliation, and expedited reporting of ICSR, special situations, device malfunctions and any other safety relevant information identified from any source (e.g. spontaneous reports by HCP or patients, literature reports, Health Authority reports).
- Maintain a communication platform for PV relevant topics in the territory. Be the primary point of communication/interface between the CSLB affiliate(s) and GCSP, ensuring a and two-way communication of any Pharmacovigilance relevant topics. Escalation of safety related issues/enquiries to both GCSP Regions and the affiliate leadership in the Territory.
- Responsible for the local PV Training in the Territory to ensure appropriate and compliant PV awareness and expertise.Manage the PV training requirements of affiliate personnel and personnel of Affiliate 3rd Parties, ensuring these personnel are aware of their PV reporting obligations and their responsibilities within the local and global PV System(s).
- Maintain compliance with PV related regulatory requirements defined in the applicable regulations of the Territory and information of GCSP regarding new PV/safety relevant regulations in the Territory.
- Maintain up-to-date information relevant for the Global Pharmacovigilance System Master File (PSMF) and local PV system (PV Sub-System File -PSSF) in the territory
- Ensure that a local PV business continuity plan exists so that ICSR handling can continue during a crisis. The PV BCP is embedded in an overarching affiliate business continuity plan.

**Requirements**:
**Education**
- Minimum Bachelor's degree of pharmacy or medicine.
- Licensed by Saudi Commission for Health Specialties.
- Have the skill for managing pharmacovigilance systems and expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences and epidemiology and biostatistics.

**Nationality**

You are a Saudi National observing local regulations.

**Experience**
- 1-2 years PV and/or Regulatory experience in the Pharmaceutical or Biotechnology industry
- knowledge of the PV relevant regulatory framework in the Territory, and sound knowledge of international PV relevant regulations and standards
- Fluent in the English and Arabic

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more abo

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