Medical Review Senior Associate Scientist Amgen Technology Private Limited

1.0 - 4.0 years

1 - 4 Lacs

Hyderabad, Telangana, India

On-site

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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) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a 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 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 Quality Assurance of ICSR medical review (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 (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their 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 representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year 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 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) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work

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QA Engineer Husk Power Systems

3 - 4 years

2 - 4 Lacs

Muzaffarpur, Patna

Work from Office

Role & responsibilities Conduct site inspections and quality audits during solar installation and construction phases. Ensure compliance with project specifications, drawings, and industry standards. Verify and document the quality of materials and workmanship. Manage NCR (non-conformance reports) and follow up on corrective actions. Assist in pre-commissioning and final quality documentation. Train site teams on quality standards and procedures. Oversee on-site inspections during Civil works, Mechanical installation, and Electrical installation. Preferred candidate profile Bachelors degree in Mechanical or Electrical Engineering. Minimum 3/4 years QA/QC experience, preferably in solar or renewable energy projects. Working knowledge of solar PV system components and installations. Familiarity with ISO 9001, IEC standards, and construction QA/QC procedures. Strong attention to detail, documentation, and communication skills.

Posted 1 month ago

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