Require Associate Scientific Manager - Clinical Development R&D in Biocon

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
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.

Post: Associate Scientific Manager - Clinical Development R&D- HC/JC/3677/2013

Job Description:
· Review and analysis of SAE reports from clinical trials
· Reconciliation of clinical trial SAEs in safety database with clinical database
· Preparation of regulatory reports e.g. Appendix XI, CIOMS I, Medwatch etc
· Ensure timely reporting of safety reports to regulatory agencies and to business partners as per the SDEA
· Triage and medical Review of ICSRs obtained from various sources e.g. spontaneous reports, literature reports, SAEs from clinical trials.
· Preparation, review and evaluation of PSURs and DSURs
· Preparation, maintenance of various regulatory PV documents including Risk management Plan (RMP), DDPS, PSMF, SDEAs etc
· Periodic review of safety data for potential signals – part of signal detection team.
· Ensuring regulatory compliance vis-a vis global Pharmacovigilance regulations.
· Preparation and maintenance of SOPs, working instructions and guidance documents and ensuring their implementation
· Preparation of safety sections in clinical study protocols and clinical study reports
· Preparation review of safety management plans for clinical trials
· Installation, validation, Implementation and maintenance of electronic safety database as and when required

Candidate Profile
1. Good knowledge of drug development process and therapeutic areas.
2. Knowledge in biologics.
3. Exposure of project management processes and problem solving skills.

Additional Information:
Experience: 7-10 Years
Location: Bangalore
Education: B.Pharm, M.Pharm, MBBS
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 12^th Jan., 2014