Manager – Phamacovigilance/ Drug Safety – Biocon Bengaluru
Manager of Phamacovigilance/ Drug Safety at Biocon, Bengaluru.
Biocon has a job opening for Manager Position in Phamacovigilance/ Drug Safety. Selected Candidate has to be the 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.
Who can Apply?
- MD in 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 and good knowledge of EMEA, Non-EU and FDA regulation.
- Strong knowledge of worldwide safety regulation for marketed and investigational products.
- Industrial knowledge and experience in drug safety and phamacovigilance and FDA and global regulations related to drug safety reporting, ICH guidelines, GCP and the process required to comply.
How to Apply?
Contact:
Arvind Padmanabhan
Biocon Limited
20th KM Hosur Road Electronic City
Bengaluru – 560100.
Ph: 91-80-28082216
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Analytical Scientist – Biocon – Bengaluru
Analytical Scientist job opening in R&D at Biocon, Bengaluru.
Biocon has a job opening for Scientist in R&D for developing Analytical methods. The Job profile includes development, optimization and validation of analytical methods to detect and quantify Biomolecules on instruments such as HPLC and/or CE; conduct tests such as purity, stability and identity studies, on Biomolecules; statistical validation of Analytical methods as per regulatory agency (ICH, USP, etc.) requirements.
Who can Apply?
- M.Sc in Biochemistry, Chemistry, Bio-Technology or Pharmacy.
- Experience of 2-4 years.
- Hands-on experience with chromatographic techniques and mass spectrometry highly desirable.
- Strong knowledge of protein chemistry.
- Sound understanding of the principles of chromatographic and/or electrophoretic separation techniques, and should be familiar with spectroscopic quantitation methods.
- Basic understanding of statistical analysis.
- Familiarity with analytical method validation will be an added advantage.
How to Apply?
Contact:
Arvind Padmanabhan
Biocon Limited
20th KM Hosur Road Electronic City
Bengaluru – 560100.
Ph: 91-80-28082216
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R&D Downstream – Biocon – Bengaluru
R&D Scientist- Downstream Position open at Biocon, Bengaluru.
Biocon has a job opening for Scientist in R&D of Downstream Process of Proteins. Candidates are required to have good understanding of protein biochemistry, protein purification and characterization. Experience in chromatographic techniques and analytical protein biochemistry is also required for the job position.
Who can Apply?
- M.Sc. in Biochemistry/ Biotechnology; Fresh graduates from Top Universities and Premiere Institutions are preferred.
- Candidate must be Proficient in protein biochemistry.
- Minimum of 2 years experience in protein purification and characterization.
How to Apply?
Contact:
Arvind Padmanabhan
Biocon Limited
20th KM Hosur Road Electronic City
Bengaluru – 560100.
Ph: 91-80-28082216
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Senior Executive – BD & Licensing – Biocon Bengaluru
Senior Executive Job opening at Biocon, Bengaluru.
Biocon has a job opening for Executive/ Senior Executive in BD & Licensing at Bengaluru. The Job profile includes the following helping with project management of Biologicals in the Biocon pipeline; tracking projects, assign priorities; helping with commercial business cases to rationalize spends; serving as a conduit between R&D, production, regulatory and sales team; helping with opportunity assessment and valuation (including competitive landscape, pricing strategies etc) for in-licensing molecules in the oncology and auto immune space.
Who can Apply?
- B.Sc. in Microbiology/ Biotechnology/ Biochemistry and MBA/PGDM in Marketing with 0-3 years industrial experience.
- Basic understanding of life sciences and work experience in BD/ Market research are preferred.
- Self motivated individual with demonstrated planning and analytical skills.
- Persuasive with good communication skills.
- Sensitive and prompt in responding to customer needs.
- High level of perseverance and resilience.
How to Apply?
Contact:
Priya, Biocon Limited
Ph: (080) -28082084
About Biocon:
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.
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