International Pharmacovigilance Network Senior Specialist

Description:

Key Responsibilities

• Serve as Vertex’s appointed Deputy RPPV located in Saudi Arabia, notified in writing to the relevant Health Authorities.
• Be continuously and permanently available to the Saudi Arabia Health Authority when required.
• Be permanently and continuously available to respond to urgent PV inquiries and to make notifications, as necessary, to the Saudi Arabia Health Authority concerning medicinal product risks, as well as additional countries when required.
• Ensure that additional information for the evaluation of the risk-benefit profile of a medicinal product is sent immediately and in full, if requested by the Saudi Arabia Health Authority.
• Assist with communication of Special Circumstance Safety Information and product recalls as required or requested;
• Maintain, on an ongoing basis, an up-to-date knowledge and thorough understanding of the local PV legislation as relevant to comply with the local PV obligations.
• Perform regular local PV regulatory intelligence surveillance for any changes to the local PV requirements.
• Perform and document local scientific and medical literature searches for potential Adverse Events and Other Safety Information as assigned.
• Communicate immediately any suspected safety issues in the country as per applicable procedure.
• Maintain up-to-date Curriculum Vitae and appropriate qualifications as required.
• Maintain compliance with all applicable training requirements.
• Be available to assist GPS Quality, Standards, and Training (QST) Team with PV audits/inspections and resulting Corrective Action /Preventative Action (CAPA), as requested
• Provide input into the preparation of regulatory actions in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals).
• Work in conjunction with GPS International PV Team to promote, maintain, and improve compliance with regulatory requirements.
• Work in conjunction with GPS QST Team to maintain the Pharmacovigilance System Master File (PSMF).
• Keeping up to date with product safety data generated because of post-authorization activities through access to systems and reports.
• Maintain awareness of the safety profiles of Vertex products, as applicable.
• Maintain awareness of risk minimization measures and the Risk Management Plan, as applicable.
• Maintain awareness of periodic aggregate reports, as applicable.
• Maintain all appropriate documentation to support procedures.
• Fulfill all other requirements as mandated by pharmacovigilance regulations.
• Support other PV activities as requested.

Education And Experience

• Bachelor’s Degree in Medicine or Pharmacy required.
• Proficiency in using Microsoft Office applications required (Word, Excel, PowerPoint; and PowerBi).
• Licensed by Saudi Commission for Health Specialties.
• Solid knowledge of pharmacovigilance system operations and function.
• Strong knowledge and documentation of education in the field of pharmacovigilance regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing setting.
• Strong operational skills as demonstrated by leading previous projects or functions.
• Excellent oral and written communication skills in English (required) and Arabic (required).
• High ethical standards, including a commitment to Vertex's values and behaviors.