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Biostatistics and Data Experts
Local Pharmacovigilance Representative – Consultant
Location
Turkey
Posted
59 days ago
Salary
0
Seniority
Senior
Job Description
Local Pharmacovigilance Representative – Consultant
Quanticate
• Research and maintain up-to-date knowledge of local safety reporting requirements • Register as the Local Pharmacovigilance Representative with relevant regulatory authorities • Prepare and submit expedited and periodic safety reports in line with local regulations • Translate safety reports, regulatory documents, and correspondence from English into the local language accurately • Provide ongoing pharmacovigilance support to internal teams as required • Work closely with pharmacovigilance teams to ensure compliance and timely submissions to Ministry of Health, Turkish Medicines and Medical Devices Agency • Liaise with local regulatory authorities to understand requirements and manage submissions effectively
Job Requirements
- Solid understanding of Turkish local pharmacovigilance reporting requirements (clinical and post-authorisation)
- Experience with Ministry of Health, Turkish Medicines and Medical Devices Agency submissions
- Fluency in English and the relevant local language (written and verbal)
- A degree in pharmacy, life sciences, or a healthcare-related field is desirable
- Experience working in clinical trials, either within a CRO, sponsor organisation, regulatory authority, or similar setting
- Proven experience submitting safety reports to regulatory authorities
- Strong grasp of scientific and medical terminology
- Excellent written and verbal communication skills
- High attention to detail and accuracy
- Strong organisational and time management abilities
- Proficiency in standard software tools such as Microsoft Word and Adobe Acrobat
Benefits
- Competitive hourly rate
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