Interprets and prepares virology data for
regulatory submissions.
A HO licence is preferred. Construct use is of two
types, one for the overexpression and other for the RNAi.
Ensure that the global pharmacovigilance database
is updated periodically. The candidate will perform data entry, data clean up, and
data loading to maintain and expand a commercially successful database of available
chemicals. For each position, I have listed a short description and a link for more
information.
After the constructs are clone into the suitable
vectors they are mobilised into the Agrobacterium Strain.
To work in accordance to GLP. Candidates well
versed with GLP, FDA and other regulatory requirements will be preferred. To produce
and manage material for a variety of scientific disciplines. Provide medical
assessments of clinical trial and spontaneous event reports.
Construct use is of two types, one for the
overexpression and other for the RNAi.
Board certified or board eligible is preferred.
Incumbent will work closely with Sales and Manufacturing Departments, as
well.
Ability to read a lot of material and condense the
information.
Make recommendations to Corporate Drug Safety
Committee, as required.
Develops and implements assays to evaluate
antiviral drug mechanisms, drug resistance mutations, and analysis of viral isolates
at the cellular and molecular level.
Manages clinical deliverables, budgets and
timelines.
Experience in sterile cell culture procedures, cell
processing is needed. Construct use is of two types, one for the overexpression and
other for the RNAi. For each position, I have listed a short description and a link
for more information.
Monitoring of Adverse Events from clinical trials.
Construct use is of two types, one for the overexpression and other for the RNAi.
Monitoring of Adverse Events from clinical trials.
Ensure regulatory compliance in respect of
pharmacovigilance. Board certified or board eligible is preferred. Expertise in one
or more of the following specialization - stereoselective synthesis, chiral
chemistry, combinatorial chemistry, heterocyclic chemistry, peptide synthesis.
Handling of instruments like HPLC, GC, FTIR, UV and IR will be an advantage. This
position will be responsible for production of analysis datasets and specifications,
well documented code, summary tables and some statistical analysis of data. Provide
pharmacovigilance input on designated products.
Exposure in patent law of USA, EP etc.
Provide pharmacovigilance input on designated
products.
Monitors protocol progress; addresses and manages
obstacles.
Prepare reports of PMS studies for regulatory
submission.
Provide medical assessments of clinical trial and
spontaneous event reports.