Role Description
- Act as Qualified Person for Pharmacovigilance (QPPV) and single point of contact for PV with Competent Authorities in KSA for products where Legacy Acino and Legacy Amoun are Marketing Authorization Holders (MAHs).
- Maintain the PV quality management system up to date.
- Adhere to Arcera internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
- Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
- All trainings to be completed as per training plan.
Key Responsibilities
- Represent the Scientific Office and the MAH in all safety related activities.
- Act as single point of PV contact for distributors, SFDA and as a contact point for Pharmacovigilance inspections. Be available on a 24-hour basis
- Keep oversight over the functioning of the PV system and implementation of standard procedural documents and processes in the KSA and NDM markets (Morocco, Libya, and Yemen), ensuring compliance and execution of PV activities across the Arcera portfolio.
- Provide local pharmacovigilance governance aligned with Global PV requirements and applicable health authority regulations
- Work closely and in collaboration with PV Head META, Global PV and external service providers.
- Establish and maintain the local PV Quality Management System (QMS) including Master documents, PSSF, SOPs etc. and submission of all pharmacovigilance related documents in accordance with the national legal requirements and GVP in KSA.
- Perform annual PV awareness training for Arcera employees in KSA and newcomers as per MAH’s procedures.
- Keep up to date with the relevant regulations and guidelines (PV Intelligence).
- Prepare and distribute the submission plan of PSURs, RMPs, DHCPs and PSMFs/PSSFs and follow-up on the implementation of RMMS in KSA, when applicable.
- Having an overview of medicinal product safety profiles and any emerging safety concerns;
- Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
- Perform and document PV Due Diligence on distributors and service providers according to internal process.
- Create Safety Data Exchange Agreements (SDEAs) with service providers and distributors and monitor their performance and compliance accordingly.
- Participate in internal and external audits of distributors and contract manufacturers.
- Adhere to Arcera internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
- Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
- Training assignments on Informetica / follow up for deadlines for Arcera employees in KSA & NDMs
- Support the PV Head META on the assigned regional tasks.
Key Skills and Competencies
Knowledge and skills:
- Strong knowledge of SFDA PV Regulations and EMA GVP guidelines.
- In-depth understanding of ICSR management, PSUR/RMP, risk management, signal detection, and safety data exchange.
- Proven experience in PV system oversight, SOPs, training, and inspection readiness.
- Good understanding of pharmacology, clinical safety, and benefit–risk assessment.
Competencies:
− High attention to detail, accountability, and ethical integrity in regulatory interactions.
− Proactive and adaptable, committed to continuous learning and compliance excellence.
- Communication & Stakeholder Management
- Teamwork and collaboration
Qualifications & Experience
- A university degree in Pharmacy, Medicine, Life Sciences, or related field.
- 2-5 years professional experience in PV in pharmaceutical industry and experience as QPPV KSA and Saudi National Guidelines.
- Good knowledge in PV regulations in KSA and the GVP Arab guidelines.
- Fluent level in English both in oral and written communication.
- Ability to maintain a structured documentation and archiving system.
- Excellent communication skills across cultures.
- Ability to work under supervision, multi-task with attention to detail and manage multiple deadlines
