Tuesday, 7 June 2016

Data Analyst Position (Pharmacovigilance)

Dear Candidate,

We have openings for Data Analyst Position (Pharmacovigilance)

Work Location: Kolkata or pune

Interview Location: Bangalore

Experience: 2-4 years

Mode: Permanent

Job Description

At least 2 years + of total experience in is must

(At least 6 months PV Experience having exposure to MedDRA, WHO- DD and narrative)

* Track all adverse event reports received and completed;
* Review and assess all source documents, and compile data in an adverse event report;
* Data enter report into the client safety database;
* Code adverse events in the client safety database;
* Release report to client through client safety database.
* Experience with WHO or MeDRA dictionaries is mandatory
* Willing to work in shifts

Note : Interested candidates can send their resume to ravali@adso.com

If you have any queries call to 9032912255

If any of your friends are interested please share this E-Mail with them..

Regards,
Ravali
ravali@adso.com
Mobile 9032912255

Job Description : Walk.in for QA & QC ( Apotex )

Walk.in for .........****
QA....Reviewer/Sr.Reviewer...2 to 8 years in QMS ( Deviation /Investigation /OOS/OOT) for regulatory market....................................***

Reviewer / Sr.Reviewer ....2 to 8 years in CAPA/Market complaints /Product complaints system /Quality rist management ..........................................***

QC ( Analyst)...2 to 6 years in Finished good/Raw material/Packing material/stability of tablets and capsules..........................PE & AS ( Analyst /Sr.analyst )..2 to 8 years in exhibit stability /method validation /method transfer & verification

Qualification : Msc/M.pharm.................Walk.in
on 11-june-2016 at Apotex,
Bangalore.............
Time : 08AM to 12:00 PM .....11-June-2016........

Venue: Apotex Research Pvt Ltd
[ARPL], Plot # 1&2,
Bommasandra Industrial Area,
Phase 4, Jigani Link Road,
Bangalore-560099.

Monday, 6 June 2016

World Health Organization (WHO) 50th report


World Health Organization (WHO) 50th report

Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 996) successfully passed the 139th session of the Executive Board on Tuesday, 31 May 2016.

(ref: http://apps.who.int/gb/ebwha/pdf_files/EB139/B139_12-en.pdf).

 
The following guidelines, as contained in the Annexes to the Expert Committee’s fiftieth report, are now recommended for use:

• Annex 1:
Good pharmacopoeial practices (new)

• Annex 2:
International Pharmaceutical Federation–WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products (new)

• Annex 3:
Guidance on good manufacturing practices for biological products (revision), following its adoption by the Expert Committee on Biological Standardization on 16 October 2015

• Annex 4:
Guidance on good manufacturing practices: inspection report, including a model report (revision)

• Annex 5:
Guidance on good data and record management practices (new)

• Annex 6:
Good trade and distribution practices for pharmaceutical starting materials (revision)

• Annex 7:
Guidelines on the conduct of surveys of the quality of medicines (new)

• Annex 8:
Collaborative procedure between WHO’s Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines (revision)

• Annex 9:
Guidance for organizations performing in vivo bioequivalence studies (revision)

• Annex 10:
WHO general guidance on variations to multisource pharmaceutical products (new).