Medical Specialist - Pharmacovigilance

Descreption & Aim

Pharmacovigilance/ Drug Safety

• Acts as a deputy for the regional QPPV,
• Contributes to daily Drug Safety and PV Quality Control operations for all medicinal products, including case management of adverse event records (triage, and analysis), assessment of incoming communication to identify potential adverse event reports and submission of expedited and periodic reports to Health authority,
• Manages Safety Medical Enquiries in a timely manner, including maintenance of standard response documents in collaboration with Corporate Medical Affairs- PV,
• Manages incoming communication for potential adverse event reports and external queries via local intake system, phone, fax, mail, digital sources and other methods,
• Organizes reconciliations with internal functions, corporate PV, business partners and other organizations,
• Participates to periodic Corporate PV meetings, if any, acting as Deputy QPPV,
• Contributes to the maintenance of the local Pharmacovigilance system including quality documentation and related indicators, audits and inspection readiness as well as the filing and archiving of relevant documentation,
• Contributes to review and assessment of researches, promotion programs and all other activities to meet regulatory PV reporting requirements,
• Assists with maintenance of the Quality System for Pharmacovigilance and Medical Information and within all local compliance regulation,
• Provides training to new employees and license partners about adverse event collection and reporting; organizes regular refresher training to employees,
• Conduct and contributes to all pharmacovigilance inspection/ audit readiness and ensure closure with proper CAPA plans implementation,
• Supporting the LDSUM in writing procedures related to activities performed at local level,
• Assuring the adequate monitoring of the local HAs websites as per current procedure,
• Other duties as necessary (Argus system management and CIOMS writing) at the proper scientific and technical level.

Company Procedure & Follow-Up Process

• Comply with the data integrity policy and commitment.
• Monitoring and analyzing the processes and ensuring that the necessary actions are taken for improvement.
• Maintaining, backing up and archiving all records under her/his responsibility as determined and destroying the records under his/her responsibility as determined when the retention period expires.
• Fulfilling and implementing responsibilities mentioned in all PV procedures of the company.
• The process managed in accordance with Company Procedures; s/he is responsible for ensuring that the activities of the inputs and outputs are correct, the resources are sufficient, the process is monitored, the records are kept, the performance is measured and, when necessary, reporting on these issues.

Education Level

Education Faculty / Department

Work Experience

Technical Knowledge

• Familiar with the medical environment and healthcare system in the Middle East and Africa,
• Familiar with applicable Local/International regulations related to Pharmacovigilance and EU GVP guidelines,
• Hold a training certificate in PV

Foreign Language

Competencies & Skills

• Highly organized with ability to prioritize own tasks as well as those of others, good planning skills,
• Able to drive multiple projects with multiple priorities, as well as have the ability to strategically think through complex opportunities,
• Knowledge in researching scientific literature and medical information and provide good command communication skills & presentation solutions,
• Analytical/ reasoning, and sound medical judgment/decision making skills,
• Strong ability to assess and summarize scientific and other technical information in a clear concise manner and target to a specific audience.
• Ability to build productive work relationships both internally and externally,
• Ability to work effectively with cross-functional teams and influence appropriate plans and actions,
• A high level of emotional intelligence to work effectively with stakeholders,
• Ability to work independently and a demonstrated self-starter.