To work in accordance to GLP. To work in accordance to GLP. Interact with pharmacovigilance units in countries.
Interact with pharmacovigilance units in countries.
Ensure that the global pharmacovigilance database is updated periodically. Make recommendations to Corporate Drug Safety Committee, as required. Responsible for planning, designing and executing clinical protocols supporting a specific therapeutic such as Oncology, Cardiology, Rheumatology or Neurology. Responsible for supporting pre-clinical and clinical development of HCV compounds. Knowledge of carrying out, prior art search using databases and Infringement analysis. Interprets and prepares virology data for regulatory submissions.
After the constructs are clone into the suitable vectors they are mobilised into the Agrobacterium Strain. Construct use is of two types, one for the overexpression and other for the RNAi. Serves as primary contact for the protocol.
Provide pharmacovigilance input on designated products.
Ensure that the global pharmacovigilance database is updated periodically.
Incumbent will work closely with Sales and Manufacturing Departments, as well.
Apply results to bug tracking system. Apply results to bug tracking system.
Pharma with experience in a similar field. Incumbent will work closely with Sales and Manufacturing Departments, as well. Apply results to bug tracking system.
Perform black-box, guerilla, and regression testing of software products as required.
Board certified or board eligible is preferred. The requirements for this position include: BA.
The candidate will also perform blood processing experiments using microfluidic systems and analyze data. Responsible for planning, designing and executing clinical protocols supporting a specific therapeutic such as Oncology, Cardiology, Rheumatology or Neurology. Experience in sterile cell culture procedures, cell processing is needed. Experience in sterile cell culture procedures, cell processing is needed.
The successful applicant will be involved in association analysis of candidate genes. Perform black-box, guerilla, and regression testing of software products as required. Knowledge of carrying out, prior art search using databases and Infringement analysis.
Prepare reports of PMS studies for regulatory submission.
Ensure regulatory compliance in respect of pharmacovigilance. Provide pharmacovigilance input on designated products, including signal detection and monitoring, formulation and preparation of ad hoc regulatory responses. A HO licence is preferred. Monitoring of Adverse Events from clinical trials.
The requirements for this position include: BA.
Monitoring of Adverse Events from clinical trials.
Effectively leads a global team of individuals assigned to the protocol.