Job ID 189974BR
Position
Title Medical Safety Writer
Division Pharma
Business
Unit Global Develop NPH
Country India
Work
Location Hyderabad
Company/Legal
Entity India
Novartis Healthcare Private Limited
Functional
Area Research & Development
Job Type Full Time
Employment
Type Regular
Job Description Lead global
cross-functional teams responsible for writing periodic safety reports within
agreed timeframes and to a high standard of accuracy, in compliance with
DS&E business rules, standard operating procedures and global regulatory
requirements. Responsible for supporting the Global Medical Safety Physicians
in the monitoring of the safety profile of newly launched Novartis products.
ü Lead cross functional expert teams to fulfill Periodic
Safety Report accountabilities (DRA, Clinical, Marketing).
ü Author along with Global Medical Safety Physicians,
regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic
Reports) for newly launched Novartis products: collecting, organizing,
analyzing, presenting the data and drafting safety medical evaluations by means
of DS&E templates and procedures.
ü Collaborate with the Medical Safety Physicians and other
line functions to monitor the safety profile of newly launched products
emerging from aggregate reporting or large data set analyses.
ü Review emerging regulatory guidelines and legislations
and identification of impact to DS&E processes.
ü Drive and Lead DS&E projects to develop new PSUR
processes in alignment with international regulations.
ü Lead the development and maintenance of safety documents
templates and Standard Operating Procedures pertaining safety aggregate
reports.
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 Review global marketing programs and establish process
for AEs collection with global marketing teams.
ü Review Risk Management Plans in close coordination with
Pharmacovigilance Compliance and Global Medical Safety groups and assess the
operational feasibility and implications of pharmacovigilance commitments.
ü Contribute to Safety Profiling Teams to newly launched
products to ensure that case reports are accurately evaluated and data based,
and have reliable and exploitable data sets when preparing aggregate reports.
ü Proactively collaborate with licensing partners and
Clinical Research Organizations to meet joint accountabilities.
ü Act as Subject Matter Expert in cross-functional projects
and external meetings.
ü Train and mentor new DS&E associates and associates
from other line functions on medical safety writing & periodic reporting
matters.
ü Deputize for Team Leader/Group Head and assist with the
recruitment of new staff.
Key Performance Indicator(s) (HR Core IT9102 ST9003)
Key Performance Indicator(s) (HR Core IT9102 ST9003)
Minimum requirements:
ü MD desirable, PhD or Pharma D as minimum requirement and
fluency in English.
ü Knowledge of other languages desirable 5 to 7 years’
experience in Drug Development or closely related areas of responsibility, with
a minimum of 3 to 5 years’ experience in safety or medical writing.
ü Excellent understanding of drug development process, GCP
and medical terminology
ü Sound expertise in large data set analyses
ü Strong negotiation, presentation and communication
skills, and ability to operate effectively in an international environment and
across functions
ü Strong organizational and project management skills
ü Ability to lead global and cross-functional work groups
ü Ability to mentor and coach
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