Senior Specialist, Local Pharmacovigilance

This is a fully remote position, open to applicants in Greece.

📋 Description

• Establish and oversee the local pharmacovigilance system, ensuring effective management of local PV activities.

• Conduct thorough literature searches at the local level.

• Gather and manage individual case safety reports (ICSRs) locally.

• Execute PV intelligence screening.

• Maintain the local PSMF, where applicable.

• Organize local data collection effectively.

• Manage local pharmacovigilance agreements.

• Modify and submit PSUR/RMP documents as necessary.

• Conduct local signal detection when applicable.

• Implement additional measures to minimize risks.

• Review materials related to local post-authorization safety studies.

• Engage in PV-related audits and inspections.

• Participate in regular project meetings.

• Provide monthly reports on the status of the local pharmacovigilance system.

• Ensure that PV training is provided for affiliate employees, service providers, and third parties.

• Collaborate with the client's global PV system and relevant global and local departments and functions.

• Develop, review, and maintain pharmacovigilance procedures related to local tasks.

• Work alongside the Deputy to share information on pertinent current PV activities.

• Identify and escalate Medical Information requests in accordance with applicable timelines.

• Maintain 24/7 availability with the country's Competent Authority for pharmacovigilance-related issues.

• Serve as the official liaison with the country's Competent Authority.

• Ensure compliance of the local PV system with national laws and regulations.

• Promptly inform the health authority about significant safety concerns, product recalls, or changes in the benefit-risk profile.

• Coordinate the distribution of national safety communications.

• Ensure updates and validations for the local pharmacovigilance system.

• Act as the internal point of contact for the EU-QPPV and global PV team.

• Take on Deputy responsibilities during both planned and unplanned absences.

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience is required.

• At least 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related area is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Business-fluent English is essential.

• Proficiency in the local language is required.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will align with local market practices.

• Commitment to equal employment opportunity principles and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Reasonable accommodations will be provided for individuals with disabilities during the employment process.