- To support global individual case safety reports regulatory reporting compliance
- To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
- To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
- To act as a significant point of contact for Case Management on medical content of ICSRs
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Support MSRT product lead if assigned
- Execute ICSR case escalation as appropriate
- Execute appropriate case follow up per SOPs
- Support medical coding conventions, and systematic process improvements for ICSR medical review
- Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.
- Support MSRT Product Lead activities for the list of expected terms in the auto label tool
- Support Quality Assurance of ICSR medical review (if applicable)
- Support training to vendor staff (if applicable) on ICSR medical review
- Mentor junior medical reviewers.
- Participate in Safety Assessment Team (SAT) (if applicable)
- Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review
- Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
- We are all different, yet we all use our unique contributions to serve patients.
- MD/DO or international equivalent AND
- 3 years of related drug safety experience
- Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class
- Proficiency in technical safety systems including the Amgen Safety database and medical coding
- Knowledge of safety data capture in clinical trials and in the post marketing environments
- Knowledge of clinical trials and drug development
- Knowledge of Amgen products and patient population (preferred)
- MD/DO or international equivalent AND
- 4 years relevant work
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Medical Review Scientist - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
Inspection Readiness:
What we expect of you
Basic Qualifications:
Preferred Qualifications:
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