SciencePharma has developed full Pharmacovigilance system as described in Volume 9A and offers it to clients. Each company is implemented to our Pharmacovigilance System which is compliant with EU requirements.
Our experienced, eager for knowledge team ensures:
- comprehensive AE management (tracking, processing, MedDRA coding, follow-up),
- medical assessment of individual case reports,
- total PSUR generation and prompt submission to Competent Authorities,
- weekly literature searches and preparation of comprehensive reports,
- advise on or complete registration process to EudraVigilance,
- electronic reporting to EMEA and Competent Authorities EudraVigilance (via EVWEB or company’s gateway),
- responsible person for EudraVigilance - the person who represents the company in registration process,
- preparation of Detailed Description of Pharmacovigilance System tailored to company's needs, based on our PV system (Module 1.8.2 of registration dossier),
- prepariation of Risk-management plans for specific products (Module 1.8.2 of registration dossier),
- Pharmacovigilance audits: assessment of company's system, indicating deficiencies and advise on needed improvements,
- acting as Local Pharmacovigilance Contact points we ensure compliance with polish legal requirements
