www.biocon.com Ltd Bangalore : Phamacovigilance, Drug Safety

[Admin]

biocon.com

Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing and global marketing, we deliver products and solutions to partners and customers in over 50 countries. We are confident that we have the defining science, world class capabilities and a focused vision to deliver the promise of new medicine to a waiting world. Today, Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year

Designation Manager -Phamacovigilance/ Drug Safety

Job Description Key Contact with the external CRO’s / global licensing partners on issues of phamacovigilance.

Review and overview of all safety data (both non-clinical and clinical).

Review and /or sign off of protocols, SOP’s, clinical study reports, IBs, IMPD.

Review safety data and participate in dose escalation decisions.

Authorship and sign off of safety monitoring plan/ risk management plan.

Lead data analysis and writing of regulatory submission document for license application and variation activities and for safety issues and questions from regulators.

Direct the setup of safety procedures and development of safety exchange agreements.

Perform activities required to serve as a PV physician.
Review local cases for the designated products.

Periodic medical literature search and review, trend analysis and signal generation and establish and maintain a network with all licensing and business partners for coordination reporting.

Provide case management and maintain phamacovigilance and drug safety operation as well as conduct medical assessment, determine additional information needed and independently generate drug safety.

Guide crisis management on drug safety and define process for drug recall.
Desired Profile • MD-Pharmacology with 6-10 yrs of experience in phamacovigilance or Drug Safety

• Experience in contract research organization or pharmaceutical / Biotechnology Company .

• In-depth clinical background is needed. Should have good knowledge of EMEA, Non-EU and FDA regulation.

• Should have strong knowledge of worldwide safety regulation for marketed and investigational products.

• Should have industrial knowledge experience in drug safety and phamacovigilance and FDA and global regulations related to drug safety reporting ,ICH guidelines, and GCP and the process required to comply.
Experience 5 - 10 Years
Industry Type Pharma/ Biotech/Clinical Research
Functional Area Healthcare, Medical, R&D
Education UG - MBBS - Medicine
PG - M.S/M.D - Cardiology, Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Obstretrics, Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, Urology
Location Bengaluru/Bangalore
Keywords phamacovigilance ,Drug Safety
Contact Arvind Padmanabhan
Biocon Limited
20th KM Hosur Road
Electronic City
Bangalore,Karnatka,INDIA 560100
Telephone 91-080-28082216
Website http://www.biocon.com/

[Guest]

I HAVE COMPLETED MD PHARMACOLOGY.
I AM INTERESTED IN YOUR JOB PROFILE.

MY EMAIL ADRESS drjigarkatwala AT yahoo.com

My NUMBER IS 9924208782

JIGAR KATWALA

[Guest]

I have Completed my Masters in Bioinformatics and looking for job.
My E-Mail id is rajay45 AT yahoo.co.in , so if there any vacancy please contact me
Thank you.

[hanumantharayappa]

sir

i have comleted b.com computer cource . so i wanted to adminstrative job lik clerical jobs and filing maintain job & store jobs. i would like working in your esteemed. company

i have got 5 years experience in the industry & institution field.

[Guest]

Respected sir,
I have 2 year 4 months experience in Intellectual property management. I have completed my M.Sc organic chemistry in 2007. Now i am pursuing PG diploma in patent law.
my contact
no 9885447582

[Guest Poster]

hello !! please provide the latest information on the current openings but not the candidature of the applied one...because it creates a confusion of whether the forum is flashing the latest news or oldest one..

[Admin]

hello !! please provide the latest information on the current openings but not the candidature of the applied one...because it creates a confusion of whether the forum is flashing the latest news or oldest one..

Hi
The forum automatically sorts the threads based on last post.

You can change the sorting order.
To do this do the following:
Goto any forum.
Below the forum you will find "Display Options" table.
Choose the option sortd by "thread start time".

[Guest Poster]

sir I am B.N.V.S. narayana studying final semister of M.sc BIOCHEISTRY in viskhapatnam requerina a job

[Guest Poster]

SIR,
I COMPLETED B.Tech (biotechnology) I INTERESTED IN JOBS IN PHARMACOVIGILENCE & CHEMI-INFORMATICSIN YOUR ORGANISATION AND I AM Very much familier with the softwares used for developing pharmaceutical databases.

[mks.222]

i complete my M.SC.(INDUSTRIAL CHEMISTRY) IN 2010. IF ANY JOB MATCHING my profile then please informe me. i am greatful to jojn yur comany.
thanks!

[rekhapurvia]

Hello Sir , I am Rekha Purvia pursuing last semester of M.Sc. biotechnology from Jaipur National University, jaipur, At completion of my dessertation work i want to join your prestigious company, so please consider my C.V. as you find me eligible for your company