Clinical Safety Physician
Tata Consultancy Services
fulltime
Health Care Provider, Human Resources, and Business Development
5+ years
Job Title: Clinical Safety Physician
Educational Qualification MBBS and/ or MD,
Required Technical Skill Set
• Literature:
o Literature review to assess ICSR, new safety signal,
for inclusion in Aggregate report, for inclusion in
DSR (Drug Safety reports).
o Provide MAH comments for selected literature
o Review of Literature Strategy
o Design and interpretation of various types of studies
in medicine, levels of evidence, study power for the
purpose of safety analyses.
o Thesaurus used for indexing medical scientific
literature, relevant for literature search strategy
tailoring (both ad-hoc and systematic).
o Review and interpretation of current expert
therapeutic guidelines for the purpose of various
safety analyses.
o Review of outputs triaged by the safety scientist for
scientific accuracy taking into consideration all of
the above criteria
• Aggregate Reports:
o Authoring Safety Sections of SSSRs, DSUR, aCO &
PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).
o Providing MAH comments to literature presented
under literature sections.
o Authoring of RMP updates & implementation plans.
o Asses the new information received on important
safety concerns for the medicinal product.
o Reviews the content prepared by the Safety
Scientist for medical, regulatory and scientific
accuracy
• Signal Management
• Review of various types of listings for Signal
Detection
• Understanding of signal journey and knowledge of
signal management systems and process
requirements.
• Perform Signal validation with a summary.
• DSR - Complete authoring, Single case analysis &
MAH comments, Drafting Overall Conclusion and
Review
• Tailoring strategy and methodology for signal
assessment
• Overall assessment of the signal based on the
presented data and respective recommendations
for action
• Reviews the content prepared by the Safety
Scientist for medical, regulatory and scientific
accuracy
Project Management
• Manage customer interface, communication and
deliverables for assigned
molecules/documents/deliverables.
• Tactical, day-to-day customer-facing leadership at
project/program level. Responsibilities include
project strategy, planning (timelines, deliverables),
scope management and project financial
management.
o Lead internal escalation meetings to ensure quick
response to any quality concerns or customer
escalations, ensuring appropriate representatives
from stakeholders and operational management are
involved as appropriate.
o Lead meetings with internal and external
stakeholders