Description

• The Safety Scientist should be willing to work in multiple projects; able to support case processing project, writing projects as an author or literature review project and support SSD as per the project requirements.

Roles & Responsibilities:

• The Product Safety Surveillance Scientist (PSS) has a primary responsibility and accountability for creating post‐marketing safety datasets, performing epidemiological analyses, and contributing to the writing of safety surveillance reports for a wide range of consumer and personal products.
  The PSS will work in close collaboration with surveillance physicians who will provide the complementary clinical review and medical assessment of these reports; with safety informatics and analytics leadership to test and implement enhanced surveillance systems capabilities; and with project management to ensure the compliance, timeliness and quality of deliverables.
  Under guidance of MSO, review disproportionalities generated by the Client Surveillance systems and signals originating from other sources.
  Triage and validate safety signals within agreed timelines and ensure proper disposition.
  Support MSO in evaluation of validated safety signals.
  Assess relevant cases and as applicable, review data from Client.
  Asses relevant cases and as applicable, review data from the Client post marketing database and related Pharmacovigilance sources such as but not limited to scientific literature and Health Authority databases.
  Provide the summary review to the MSO and surveillance physicians for their input.
  Track signal disposition in relevant tracking tool
  Communicate arising issues to the MSOs and surveillance physicians.
  Ensures filing of the developed documentation

Requirements

• Qualification: MBBS / MD with experience as Medical Reviewer

Years of Experience

• Should have 2 to 3 years on experience in Signal management activities.

Skills

• Experience in case processing and few months of SSD experience.
  Excellent written and verbal communication skills in English