Scientist Job at Amgen: Apply for a Medical Review Senior Associate Scientist Role
Are you looking for a high-impact scientist job in global pharmacovigilance? Amgen is hiring a Medical Review Senior Associate Scientist in Hyderabad under its Global Patient Safety division. This opportunity is ideal for MD professionals seeking Amgen careers and advanced MD jobs in drug safety, medical review, and regulatory compliance within a global biopharmaceutical organization.
Job Details:
- Job Position: Medical Review Senior Associate Scientist
- Category: Safety
- Organization: Global Patient Safety
- Job ID: R-235713
- Location: Hyderabad
About the Company:
Amgen is a leading global biotechnology company committed to discovering, developing, manufacturing, and delivering innovative human therapeutics. Through its strong focus on science and patient safety, Amgen continues to build impactful Amgen careers across research, safety, regulatory, and clinical development domains. The organization’s Global Patient Safety division plays a critical role in ensuring the safety of patients worldwide by maintaining robust pharmacovigilance systems and regulatory compliance standards.
Job Description:
The purpose of this scientist’s job is to provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products and to support global individual case safety reports regulatory reporting compliance. The role assures the medical validity of ICSRs and provides input to the activities of the Medical Safety Review Team (MSRT). The selected candidate will execute medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness, to ensure high-quality safety reports. The position also acts as a point of contact for Case Management regarding the medical content of ICSRs.
Qualifications:
- Education: MD/DO or international equivalent and 1 year of related drug safety experience
- Preferred: MD/DO or international equivalent plus 3 years of relevant work experience
Key Responsibilities:
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports and produce medically accurate ICSR reports
- 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 a reportability assessment for medical device-associated events and/or product complaint-associated events, and review for potential product problems
- Support Quality Assurance of ICSR medical review (if applicable)
- Provide input on interdepartmental and cross-functional initiatives, including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics related to medical review (if applicable)
- Perform other duties related to the position as defined in SOPs or as requested by the supervisor
Inspection Readiness
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be the representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role and responsibility
Knowledge and Skills Required:
- 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 Safety Database and medical coding
- Knowledge of safety data capture in Clinical Trials and Post Marketing setting
- Knowledge of clinical trials and drug development
- Knowledge of Amgen products and patient population (preferred)
