Job Description
1. Performs single case medical review in the safety database or on line listings of Oncology marketed products.
2. Author or co-authors the medical sections of the Periodic Safety Update Reports (PSURs) including literature review and analysis of known and potential risks de-fined in the Risk Management Plan (RMP).
3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR), Development Safety Update Report (DSURs), Core Data Sheets (CDS) and investigator’s brochure (IBs).
4. Assist the BSL in monitoring the safety profile of products assigned
5. Assist the BSL in preparation of safety data presentation to Safety Management Team (SMT) meetings, SIGDET and MSRB meetings
6. Assist in the development and maintenance of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures
7. Assist the BSL in clinical safety activities as needed, including and not limited to the review of clinical study protocols and review of clinical study reports (CSRs) and/or review of submission documents.
8. Provides support as required for licensing activities, regulatory inspections/audits.
Minimum requirements
- 3-6 years prior experience in clinical research or its equivalent, a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral
- Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
- Excellent understanding of physiology, pharmacology,
- Excellent understanding of clinical trial methodology, GCP and medical terminology
- Attention to detail and quality focused
- Ability to operate effectively in an international environment,
- Ability to work independently, under pressure
-Strong technical and problem solving skills
