Job Description

Job Scope Follow up on product safety surveillance for the Company by maintaining the pharmacovigilance system that fulfils compliance with internal procedures and external requirements. Ensure communication to PV head for any relevant change in relation to the product portfolio, clinical trials and post marketing activities, local processes, local PV regulations, audits and inspections, and health authorities’ requests, and maintain PV system documentation, acting as QPPV.

Job Requirements Education

Bachelor’s degree of pharmacy or medicine, basic training in epidemiology and biostatics.

Eligibility for this role is limited to Saudi nationals in accordance with applicable government regulations.

Experience 1-2 years of experience in pharmaceutical Medical Affairs, Marketing or Sales.

Language

Proficiency in written, read and spoken English and Arabic.

Professional Knowledge

• Basic understanding of pharmacology and drug safety concepts.
• General knowledge of pharmaceutical industry and regulations.
• Medical terminology and documentation basics.

Main Competencies

• Basic knowledge of pharmacovigilance and related medical and scientific fields.
• Attention to detail and ability to work under pressure.
• Strong communication skills.
• Critical thinking ability.
• Ability to handle confidential information.
• Good organizational skills.
• Extensive knowledge of MS Office Applications and systems.
• Teamwork and willingness to learn.

Duties and Responsibilities (But not limited to)

Executive & Technical Duties

• Fulfil qualified person for pharmacovigilance QPPV (duties) as per the assigned role by the PV head.
• Act as the primary point of contact for the regulatory/health authority.
• Monitor and keep abreast of changes to local PV/Regulatory legislation and published literature in KSA regarding safety concerns of MS Pharma medicinal products and those of the same class, and promptly forwarding to corporate PV / Regulatory Department.
• Communicate to the Global MS Pharma PV/ Regulatory team immediately (or within the latest one (1) working day) any discussions with regulatory / health authority.
• Support the Global MS Pharma PV team on the addressing the local regulatory authority request for information which may include translation, response review and meeting participation.
• Case processing and submission of safety case reports to concerned local authorities and parties as per process.
• Preparation /Submission / review of PV documents (periodic reports, annual safety reports, Risk Management Plans / Risk Minimization Measures) in accordance with the legal requirements and good pharmacovigilance practice and as per company system process.
• Perform all related pharmacovigilance labelling and packaging review and documentation as per PV system process.
• Perform local non-indexed literature screening as per MS Pharma procedure and local requirement.
• Local management /oversight of the pharmacovigilance system master file (PSMF) and national pharmacovigilance sub-system file (national PSSF) including the overall functioning of the PV system in all relevant aspects, such as quality system and compliance, adverse reaction database, changes and validation status of the database, ongoing or completed clinical trials and other studies as marketing authorization holder (MAH) is aware of and which may be relevant to the safety of the medicinal products; oversight of potential sources of safety information e.g. from those with whom MS Pharma has contractual arrangements;
• Support Audits and Inspections, as required, including attendance, provision of registered documentation and of completion of Corrective and Preventive Actions (CAPAs), if needed.
• Ensure full understanding of MS Pharma products, their safety profiles, and any issues.
• Assist with the attainment of follow-up safety information from healthcare professional, or consumers /patients.
• Maintenance of documentation and archiving as per process.
• Complete training relation to pharmacovigilance system and maintain up to date training file.
• Promoting, maintaining, and improving compliance with local legal requirements and maintaining up-to -date knowledge of current PV regulations.
• Read and understand all PV procedures and process when provided.
• Attend / deliver training, as requested.
• Maintain PV role related to the activities of the department, mainly act as Subject Matter Expert for Global Pharmacovigilance Partner Alliance Management activities including preparation and maintenance of SDEAs and /or other applicable PV agreements.
• Support management of the HQ PSMF and related Annexes.
• Maintenance of PV Regulatory Intelligence updates.
• Responsible for monthly reconciliation with HQ offices.
• Handle any other work-related activities as per the direction of the Manager.