Clinical Study Physician - Associate - Sr Manager
Location: Bengaluru, Chennai, Gandhinagar, Hyderabad, Indore, Kolkata, Mumbai, Nagpur, Noida, Pune
• Experience: Senior Level
• Openings: 3
Job description
Education MBBS/MD/MS
Literature review to
assess ICSR, new safety signal, for inclusion in Aggregate report, for
inclusion in DSR (Drug Safety reports).
Design and
interpretation of various types of studies in medicine, levels of evidence,
study power for the purpose of safety analyses.
Authoring Safety
Sections of DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).
Authoring of RMP
updates & implementation plans.
Review of various
types of listings for Signal Detection
Understanding of
signal journey and knowledge of signal management systems and process
requirements.
DSR - Complete
authoring, Single case analysis & MAH comments, Drafting Overall Conclusion
and Review
Must have skillset
ICSR
Aggregate Reporting
Signal Management
RMP