Job ID 206252BR
Position Title Principal Pharmacovigilance
Scientist
Division Global Drug Development
Business Unit CMO & PATIENT SAFETY GDD
Country India
Work Location Hyderabad
Company/Legal
Entity Novartis Healthcare Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description Responsible
for monitoring the safety profile of newly launched Novartis products in
collaboration with the Global Medical Safety Physicians , including authoring
complex aggregated safety reports within agreed timeframes and to a high
standard of accuracy, and evaluation & quality check of Individual Case
Safety Reports (ICSR), in compliance with DS&E business rules, standard
operating procedures and global regulatory requirements. Lead Global DS&E
initiatives in collaboration with other Global Line Functions to develop
business solutions and meet regulatory requirements.
ü
-Collaborate with
the Medical Safety Physicians and other line functions to monitor the safety
profile of newly launched products, by analyzing large data sets, reviewing
clinical study protocols, responding to inquiries from Health Authorities,
drafting communications to Health Care Professionals, and responding to CPO
requests.
ü
-Lead Global
DS&E initiatives to develop business solutions and meet emerging regulatory
requirements, by directing cross-functional teams, managing progress, quality
and timely completion of deliverables, and reporting progress to DS&E
leadership.
ü
-Develop
procedures to monitor Central DS&E and CPO compliance to regulatory
requirements.
ü
-Drive the quality
review/sampling of ICSRs and literature as part of DS&E quality management
system. -Review global marketing programs and establish process for AEs
collection with global marketing teams as required.
ü
-Review Risk
Management Plans in coordination with Global Medical Safety groups and assess
the operational feasibility and implications of pharmacovigilance commitments
as required.
ü
-Proactively
collaborate with licensing partners and Clinical Research Organizations to meet
joint accountabil-ties.
ü
-Collaborate with
Electronic Data Management team to reconcile Serious Adverse Events between the
Clinical and Safety databases to meet joint accountabilities and enable locking
of Clinical database.
ü
-Co-lead Safety
Profiling Teams for newly launched products to ensure that case reports are
accurately evaluated and data based, and authoring Product Specific Guidelines
for assigned products.
ü
-Lead the
preparation of Standard Operating Procedures and Argus processing conventions.
ü
-Develop and test
safety systems/IT applications as business lead/co-lead and support the
preparation of relevant manuals.
ü
-Review emerging
regulatory guidelines and legislations and identification of impact to DS&E
processes.
ü
-Lead sessions
during Health Authorities inspections and audits as Subject Matter Expert, and
lead the development and implementation of Corrective and Preventative Actions
(CAPA) to address safety findings.
ü
-Act as Subject
Matter Expert in cross-functional projects and external meetings. -Train and
mentor new DS&E associates and associates from other line functions.
ü
-Deputize for Team
Leader/Group Head and assist with the recruitment of new staff.
1. Ability to lead
cross-functional teams and represent DS&E at external meetings.
2. Drive continuous DS&E business improvements by initiating &
managing initiatives.
3. Number, timeliness and quality of deliverables according to established
directives.
4. Role model of company values & behavior.
Minimum
requirements: Bachelors or
Master degree in Life sciences or Pharmacy as a minimum requirement MD
desirable, PhD or Pharm D
desirable Fluency in English.
ü
Knowledge of other
languages desirable.
ü
4 to 7 years
experience in Drug Development or closely re- lated areas of responsibility, with
a minimum of 3 to 5 years’ experience in drug safety
ü
Excellent
understanding of drug development process, GCP and medical terminology
ü
Strong
negotiation, presentation and communication skills, and ability to operate
effectively in an international environment and across functions and sites
ü
Strong
organizational and project management skills
ü
Ability to lead
global and cross-functional work groups
ü
Ability to mentor
and coach
Last Date: 21st March, 2017
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