- 1. To prepare Individual Case Safety Report (ICSR), quality control (QC)
2. To track and close processed ICSRs
3. To perform ICSR reconciliation with business partners, if required
4. To review literature screening search results, identifying ICSRs and other safety-related findings.
5. Preparation of PSURs and RMP documents as and when required. This may include acting as the project co-ordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.
6. To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required.
7. To assist in preparation for any internal audits or external inspections on companys pharmacovigilance function.
8. To liaise with Clinical Research personnel in the preparation of safety data required in support of the clinical research programme.
9. Responsible for day-to-day processing of incoming adverse event reports and reporting to regulatory authorities, with the objective of achieving a high level of regulatory compliance.
10. To respond to all medical and technical enquiries accurately and in accordance with current opinion/knowledge, the published literature etc.
11. Contact with regulatory authorities (e.g. MHRA pharmacovigilance or GCP personnel), usually by e-mail or via websites such as Eudravigilance or MHRA Portal.
12. Ensuring that all medical information queries from external customers are handled accurately and in a timely manner, consistent with customer expectations.
13. Assisting in drafting CTD, responding to queries.
14. Ensuring that all other activities such as archiving and assistance with quality assurance activities are prioritised appropriately.Company Profile:
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