Job Description:
Major Activities (Describe main activities)
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.
5. 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.
6. Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection.
7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic reports, collecting, organizing and presenting the available data.
8. Work with external partner groups, e.g. colicensing partners and Clinical Research Organisations to meet joint accountabilities
9. Represent DS&E at internal and external meetings
10. Assist the Medical Safety Physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.
11. Assist the Medical Safety Physicians in monitoring the safety profile of product
12. Be involved in development and testing of safety systems/IT applications and in the prepara-tion of relevant manuals.

Novartis ($NVS) temporarily pulled the curtains on its Lincoln, NE, consumer drug plant in late December. What's been going on behind those windows? Pharmalot reports that, after a recent visit, FDA inspectors filed a 483 report on several manufacturing and quality control problems, including reporting failures and consumer complaints about rogue products in Novartis packages.

For instance, Excedrin migraine tablets were mixed up with Excedrin migraine caplets, and Novartis didn't fully investigate the problem batches, the report stated. The company concluded the problem wasn't within its control, Pharmalot reports, but the FDA says that's not plausible, because both drugs were packaged on the same line. What's more, Novartis didn't offer any evidence to support its conclusion the product mix-up stemmed from theft.

Indeed, the FDA said, none of the 223 "critical complaints" received were properly reviewed by Novartis. The company didn't have enough people assigned to probe the complaints, and those it did have weren't adequately trained. The plant wasn't likely to get more resources from corporate, either, given that higher-ups weren't alerted to some of the product mix-ups for two years.

Novartis can take heart from other product mix-ups that have plagued drugmakers of late. Mylan ($MYL) had to recall two drugs after labels for one were mistakenly applied to bottles of the other. Pfizer's ($PFE) Greenstone unit recalled bottles of its antidepressant citalopram because they might have contained the prostate drug finasteride. And Endo Pharmaceuticals ($ENDP) yanked two lots of its Endocet pain reliever after some higher-strength tablets were found mixed in with a lower-strength version.

- read the Pharmalot news

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