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Complaint Trending (Signal Management) Engineer

5-9 years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Complaint Trending (Signal Management) Engineer – Hyderabad, India

Location: Hyderabad, India
Work Mode: On-site
Company: Amgen
Job ID: R-219501
Posted On: June 30, 2025


Job Summary:

Amgen is hiring a Complaint Trending (Signal Management) Engineer to join its Post Market Surveillance & Trending group in Hyderabad. This role involves analyzing complaint and adverse event data, identifying safety signals, generating product surveillance metrics, and supporting audits and regulatory inquiries. Ideal for professionals with a strong background in medical devices, combination products, and data analysis within the biotech or pharmaceutical industry.


Key Responsibilities:

  • Conduct deep dives into statistical complaint trending and signal detection.

  • Evaluate adverse event and complaint data to identify quality and safety signals.

  • Support integrated surveillance efforts across quality and safety functions.

  • Collaborate with design, quality, and manufacturing teams for device improvements.

  • Generate process surveillance metrics for internal governance.

  • Respond to ad-hoc regulatory inquiries with data-backed analysis.

  • Contribute to AI/ML innovation projects in post-market surveillance.

  • Support audits, inspections, and continuous improvement in trending methodologies.


Required Skills & Qualifications:

  • Bachelor’s or Master’s in Engineering or Life Sciences.

  • 5–9 years of experience in quality or manufacturing roles within the biotech or pharmaceutical sector.

  • Minimum 3 years working with complaints/trending in development, manufacturing, or post-market settings.

  • Knowledge of Class II and Class III medical devices and combination products.

  • Understanding of product complaint and adverse event processing.

  • Strong data analysis skills; familiarity with Tableau, Power BI, or Python.

  • Experience with statistical trending methodologies.

  • Excellent cross-functional collaboration and presentation skills.


Preferred Skills:

  • Hands-on experience with electromechanical medical devices.

  • Knowledge of global safety regulations for medical devices and combination products.

  • Strong data querying and business intelligence experience.

  • Passion for identifying data-driven safety signals.


Perks & Benefits:

  • Competitive base salary plus comprehensive Total Rewards Plan aligned with local market standards.

  • Collaborative, inclusive, and innovation-focused work environment.

  • Opportunities to work with cutting-edge technologies including AI/ML in product safety.

  • Professional growth and advancement in a globally respected biotech company.


Company Description:

Amgen is a leading global biotechnology company dedicated to unlocking the potential of biology for patients suffering from serious illnesses. With a focus on medical innovation, device safety, and regulatory excellence, Amgen offers a dynamic environment for healthcare professionals passionate about improving lives.


Call to Action:

Ready to lead the way in post-market surveillance and complaint signal analysis? Apply now to join Amgen’s Hyderabad team and make an impact in global medical device safety.