Local Pharmacovigilance Representative – Consultant

Job Description

We are seeking a Consultant Local Pharmacovigilance Representative to ensure compliance with local pharmacovigilance requirements in Turkey. The role involves regulatory safety activities and collaboration with health authorities. Key Responsibilities: - Stay updated on local safety reporting requirements through continuous research. - Register as the Local Pharmacovigilance Representative with relevant regulatory bodies. - Prepare and submit safety reports, both expedited and periodic, in accordance with local regulations. - Translate safety reports, regulatory documents, and correspondence from English into the local language, ensuring accuracy. - Provide ongoing pharmacovigilance support to internal teams as needed. - Collaborate closely with pharmacovigilance teams to ensure compliance and timely submissions to the Ministry of Health, Turkish Medicines and Medical Devices Agency. - Effectively communicate and manage submissions with local regulatory authorities to understand their requirements.

Qualifications

Key Requirements: 1. In-depth knowledge of Turkish local pharmacovigilance reporting requirements, covering both clinical and post-authorization phases. 2. Prior experience with submissions to the Ministry of Health, Turkish Medicines and Medical Devices Agency. 3. Proficiency in both English and the relevant local language, encompassing written and verbal communication. 4. A degree in pharmacy, life sciences, or a related healthcare field is preferred. 5. Previous experience in clinical trials, whether within a CRO, sponsor organization, regulatory authority, or a similar environment. 6. Demonstrated experience in submitting safety reports to regulatory authorities. 7. A solid understanding of scientific and medical terminology. 8. Excellent written and verbal communication skills. 9. High level of attention to detail and accuracy. 10. Strong organizational and time management skills. 11. Competence in using standard software tools like Microsoft Word and Adobe Acrobat.

Benefits

- Competitive hourly rate will be provided.