Novartis
Job Title: Pharmacovigilance Scientist
No. of Posts: 1
Job Description:
1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms.
3. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed.
4. Determine the necessity for follow-up and prepare follow-up request as needed.
1. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased.
2. Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection.
3. Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data.
4 Work with external partner groups, e.g. co-licensing partners and Clinical Research Organisations to meet joint accountabilities
5. Represent DS&E at internal and external meetings
6. Assist the Medical Safety Physicians with project activities in
7. Assist the Medical Safety Physicians in monitoring the safety profile of product
8. Be involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals.
9. Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs Impact on the organization:
• Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements
• Alert the Medical Safety Physicians to potential safety issues
Qualifications:
- Education (minimum/desirable): Life sciences degree / Nursing background Languages: Good knowledge/fluency in English.
- Knowledge of other languages desirable. Experience/Professional requirement:
- Experience in drug safety / Development or closely related areas of responsibility
- Experience of safety document writing Good negotiation and oral communication skills
