Pharmacovigilance, Senior Specialist in SPIMACO

About SPIMACO

SPIMACO, The Saudi Joint-Stock Company Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO) has a fully paid-up capital of SR 1,200,000,000. It began back in 1986. The development, production, and marketing of pharmaceutical items and medical equipment are the core business of SPIMACO Addwaeih. Additionally, SPIMACO controls a variety of limited liability and joint stock firms both inside and outside the Kingdom. With a solid base to service export markets and a developed strong presence in Saudi Arabia, SPIMACO is well-positioned to maintain its expansion.

About the job

Responsibilities:

• Review of pharmacovigilance protocols; recommendations on necessary and preferred pharmacovigilance activities for adherence to standard operating procedures, suitable regulatory, institutional, and local rules and regulations.
• Register the pharmacovigilance employees as a deputy QPPV to the SFDA.
• When the chosen QPPV is temporarily unable to complete his or her duties, acts as a backup.
• Monitor the medical goods of the represented company after registration and marketing, and notify SFDA of any findings about the quality, effectiveness, and safety of those products in line with pharmacovigilance regulations in all countries (Saudi Arabia and export countries).
• To support data safety and case tracking, you are in charge of local and necessary global pharmacovigilance actions. You are also in charge of document archiving, helping to run pharmacovigilance meetings, and supporting the calibre of review documents.
• Support the organisation and execution of pharmacovigilance operations, including as employee training, the creation and revision of SOPs, and continuous SOP reviews.
• Ensure timely notification of safety-related issues, in line with institutional and relevant legislative statutes and regulations.
• Make sure that all pharmacovigilance-related activities are done in line with the law and GPV, as well as that all papers relevant to them are provided.
• Conducting and continues updating of the pharmacovigilance system master file PSMF.
• Participate in company signal management operations, and help identify and evaluate safety signals from all sources available for potential submission to the Saudi FDA.
• Review of audit / inspection reports, preparation of CAPA response documents.
• Prepare training materials and deliver pharmacovigilance training for all SPIMACO’s employees.
• Assist with regulations and/or procedures, providing scientific coordination, and reviewing promotional materials, scientific presentations, and other scientific office tasks.
• Performs other related duties and tasks as directed.

Qualifications and experience:

• Bachelor Degree in Pharmacy or Medicine.
• Minimum of 3 years in a similar role.
• Licensed by the Saudi Commission for Health Specialties (SCFHS).
• Proficiency in English.