Compliance & Pharmacovigilance Specialist

Job Description

• Update regarding IFDA regulations.
• Review and interpret new regulations and assess their impact on company operations.
• Maintain a comprehensive knowledge of current regulations affecting the pharmaceutical industry.
• Conduct compliance monitoring to assess compliance with established policies and procedures.
• Identify areas of non-compliance and work with relevant departments to implement CAPA (corrective actions/preventive actions).
• Prepare and present compliance findings to the management team and recommend improvement actions.
• Assist in the development and implementation of compliance policies and procedures to mitigate risks.
• Develop training materials and conduct training sessions on compliance topics to promote awareness and adherence for all employees.
• Create training materials and conduct training sessions to educate employees on compliance matters, ethical standards, and regulatory requirements.
• Evaluate the effectiveness of training programs and make necessary adjustments to improve understanding of compliance.
• Conduct risk assessments to identify potential compliance gaps and risks within the organization; recommend CAPA (corrective actions/preventive actions) and improve the processes.
• Collaborate with the risk management team to develop strategies to mitigate identified risks.
• Review and update compliance-related documentation, including SOPs, and guidelines.
• Prepare compliance reports for management of the company; track and follow up on compliance issues and corrective actions.
• Highlight compliance status, risks, and action plans.
• Work closely with various departments (e.g., All Business Units, Operation Excellence, Finance, HR, Legal, Supply Chain) to ensure compliance is integrated into all processes.
• Participate in BU congresses, seminars, and cycle meetings to present updated compliance activities.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• 2 to 3  years of experience in compliance, quality assurance, or regulatory affairs within the pharmaceutical industry.
• Strong understanding of compliance requirements and industry standards.
• Excellent written and verbal communication skills for reporting and training purposes.
• Strong analytical and problem-solving skills to assess compliance risks and develop effective solutions.
• Strong written and verbal communication skills in English.
• Strong skills in Microsoft Office.