Kinjal Dave Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat

• Review entire end to end process stating from Protocol review to draft report review to ensure regulatory compliance within challenging timelines
• Manage and conduct review of Pharmacokinetics and Statistical analysis data in reference to protocol and regulatory requirement
• Provide support to response regulatory queries and execute trend analysis to identify system gap or system improvement scope based on regulatory quires/ observation
• Conduct in-process audit of clinical process as well as retrospective audit of clinical data
• Provide support for SAE handling to ensure compliance to regulatory requirement as well review SAE handling documents retrospectively
• Report non-conformity observed during system audit as well as study audit and provide corrective and preventive action

Ahmedabad, Gujarat

• Follow project specific guidelines without any deviation.
• Completes all the daily basis and monthly targets with accuracy and precision as per client requirements within challenging timelines
• Study Medical records of U.S. patients as provided and enter relevant correct codes for patient medical conditions on company’s internal portal.

Ahmedabad, Gujarat

• Preparation of Final Volume-II.
• Preparation of Method Validation report, Amendment Addendum report, Synopsis in co-ordination with Group Leader, Sr, Scientist and Scientist.
• Preparation of 100 percent numerical data and 20 percent of chromatograms per project.
• Preparation of FDA table & EU table, Formatting SOPs, Updating and Checking Working/Reference Standards list by every 15 days.
• Perform other activities with the concern of General Manager.

Ahmedabad, Gujarat

• As a Pharmacist: check out prescriptions properly and dispensed medicines to the costumers.
• Upgrade the new trainee pharmacist/pharmacy assistance or Rx manager with upcoming new drugs or medicine and OTC (Wellness) products in the market as well as available in the store.
• Make a day to day indent of medicines and wellness products as a customers needed.
• If needed call a doctor for query regarding patient’s medication.
• Arranged all medicines and OTC products as well maintained.
• Make a list of near expiry medicines and OTC product and out from the list and make purchase return.