TEVA Pharmaceuticals Hiring Pharmacovigilance Associate II Any Bachelors of Science Apply Now
Job Description
Case Intake,
Review, Triage, Date Entry, Reportability Assessment & E2B transmission:
Responsible for
triaging of adverse event information , including extraction, upload and triage
of XMLs
Performs case
registration of adverse event reports by entering searchable information and
performing duplication checks
Responsible for
sending adverse event information to in license partners within the required
timeline as per pharmacovigilance agreement
Responsible for
collecting additional information from reporters and performing follow-up with
health care professionals and consumers
Review and
assessment of reportability of the adverse event to FDA/Health Canada as
applicable
Responsible for
receiving, reviewing and performing all necessary actions pertaining to
negative acknowledgements for FDA and Health Canada as applicable
Pharmacovigilance
QMS:
Participate in
Pharmacovigilance audits and inspections as needed
Responsible for
drafting and finalizing CAPAs as needed for late submissions and non-compliance
with internal processes.
Responsible to
complete all training and SOP/WI reviews in a timely manner
Assist in
updating and revising SOPs/WIs whenever processes and procedures are changed to
comply with new regulations or to improve procedures of make them more
efficient
Train all the
new hires in PhV on systems and processes relating to pharmacovigilance
activities and present information/ training in Face-to-Face settings.
Qualifications
5-7 years of
Health care or Pharmaceutical industry experience and at least 3 years of
Pharmacovigilance experience
Bachelors of
Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology,
anatomy, pharmacology)
Rph or RN or
Degree in the field of Medicine or Pharmacy or Nursing or equivalent
combination of education and related work experience
Function Regulatory
Affairs
Sub Function Pharmacovigilance
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