Kaztronix
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Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. And foreign, in compliance with SOPs, US regulations, and international regulations. This position is also responsible for self-initiated quality review within each distinct process step. Experience: 6 to 9 years. Routine safety surveillance/signal detection Labelling Medical literature review Contribution to/Creation of regulatory responses Review of outsourced reports
Skills: Global pharmacovigilance experience and Consumer health background
Flexible to working with many different compounds Ability to make quick assessments to meet strict deadlines Medical writing/literature review experience Education:
Health care professional - PharmD or Physician
Sr Drug Safety Specialist III
Iselin, NJ US
Posted: 10/25/2023
2023-10-25
2023-12-29
Industry: Scientific
Job Number: 23-00532
Job Description
Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. And foreign, in compliance with SOPs, US regulations, and international regulations. This position is also responsible for self-initiated quality review within each distinct process step. Experience: 6 to 9 years. Routine safety surveillance/signal detection Labelling Medical literature review Contribution to/Creation of regulatory responses Review of outsourced reports
Skills: Global pharmacovigilance experience and Consumer health background
Flexible to working with many different compounds Ability to make quick assessments to meet strict deadlines Medical writing/literature review experience Education:
Health care professional - PharmD or Physician