Officer - Pharmacovigilance (medical Writer) 1 - 5 YearsMumbai

Job Description

1. Preparation of Aggregate Safety Reports (ASR) for regulatory submissions
2. Quality review of Aggregate Safety Reports 
3. Preparation and maintaenance of ASR tracker

APPLY ONLINE

Clinical Research, Records Management Associate (0 - 3 yrs exp)-

Walkin Interview from 19th November to 20th November from 10 AM
Job Requirements:

1. Downloading, Quality check and Indexing TMF documents

2. Importing individual documents with the help of eTMF3 

    application or preparing batch import script in case eTMF3 

    servers are down

3. Communicating any issues, queries with Trial Document

    Manager and acting on the resolution

4. Maintaining study trackersGood Communication Skills

5. MS Office knowledge

5. Willingness to work in Night Shifts

5. Min 6 months relevant experience (Mandatory) 

Location- Pune (Talawade)

Contact Details

Recruiter Name:Vishal Salve

Contact Company:Syntel Ltd

Telephone:020-30615000

Reference Id:Clinical Research

Playing it Safe With Eggs -What You Need to Know

Fresh eggs must be handled carefully to avoid the possibility of foodborne illness, often called "food poisoning." Even eggs with clean, uncracked shells may occasionally contain bacteria called Salmonella that can cause an intestinal infection.

The U.S. Food and Drug Administration (FDA) estimates that 142,000 illnesses each year are caused by consuming eggs contaminated withSalmonella. FDA has put regulations in place to help prevent contamination of eggs on the farm and during shipping and storage. But consumers play a key role in preventing illness associated with eggs. In fact, the most effective way to prevent egg-related illness is by knowing how to buy, store, handle and cook eggs — or foods that contain them — safely. Follow these safe handling tips to help protect yourself and your family. Read More

Clinical Trials and Human Subject Protection

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.  Many countries have adopted GCP principles as laws and/or regulations.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from this site.  International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here.  Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally. Read More