Instagram
youtube
Facebook

Associate Manager, Product Surveillance

5–8 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences 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

🏷️ Position Title:

Associate Manager, Product Surveillance
Req #: JR - 182081
Location: Gurgaon, Haryana, India
Company: Baxter International Inc.
Apply Now | Save Job


🧭 Position Overview

At Baxter, this role directly contributes to patient safety through managing post-market complaint handling processes. As an Associate Manager – Product Surveillance, you will supervise a team that handles product complaints across multiple product lines while ensuring compliance with global regulatory standards such as FDA, ISO, and Baxter Quality Systems.


🛠️ Key Responsibilities

👥 Team Supervision & Leadership

  • Supervise and guide the Product Surveillance team to meet operational goals and KPIs.

  • Distribute daily assignments to ensure timely complaint processing and regulatory reporting.

  • Monitor team performance and ensure adherence to compliance protocols.

🧠 Subject Matter Expertise

  • Serve as a Subject Matter Expert (SME) for Post-Market Surveillance (PMS) processes.

  • Stay updated with current regulatory requirements and ensure team alignment.

📈 Reporting & Analytics

  • Create and analyze operational metrics to identify trends and improvement areas.

  • Provide regular updates to management on team performance and key metrics.

🚨 Escalation & Risk Management

  • Identify and escalate high-risk issues to PMS leadership in a timely manner.

  • Participate in resolving escalated issues and contribute to risk mitigation strategies.

🔍 Audit & Compliance

  • Participate in internal and external audits as a PMS process SME.

  • Support audit readiness efforts, including document preparation, audit responses, and follow-ups.

🔄 Continuous Improvement

  • Lead or support NCRs, CAPAs, and other cross-functional improvement projects.

  • Contribute to procedural enhancements and best practice implementations.

📋 Additional Responsibilities

  • Perform additional PMS tasks as assigned by the line manager.


📌 Qualifications & Skills

🎓 Education

  • Bachelor’s degree (preferred in Science or Engineering)

💼 Experience

  • 5–8 years of experience in Quality Assurance or related field in the medical products industry

  • Experience in leading people, either directly or through project teams

🔑 Core Competencies

  • Strong understanding of complaint processes and regulatory reporting (e.g., FDA, ISO)

  • Effective verbal and written communication across all levels

  • Strong leadership, team motivation, and influence skills

  • Excellent problem-solving, critical thinking, and decision-making abilities

  • Detail-oriented with strong technical writing skills

  • Ability to thrive in ambiguous environments and adapt quickly

  • Strong customer focus and collaborative mindset


💡 Success Profile Traits

  • Detail Oriented

  • Continuous Learner

  • Courageous

  • Collaborative

  • Critical Thinker

  • Influential


🌱 Employee Benefits

  • Support for Parents

  • Continuing Education & Professional Development

  • Health & Well-being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer


📍 Work Location

Baxter (India) Pvt. Ltd
5th Floor, Tower A, Building No.9
DLF Cyber City, DLF Phase - III
Gurgaon – 122002, Haryana, India


⚖️ Equal Opportunity Employer

Baxter is an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, or veteran status.


Reasonable Accommodations

If you require a reasonable accommodation due to a disability or medical condition, please contact us here with your request and contact information.


⚠️ Recruitment Fraud Notice

Baxter has identified employment scams by individuals impersonating recruiters or employees. To stay protected, please review Baxter’s official Recruitment Fraud Notice.


📩 Apply Now

Click here to submit your application.
Save Job | Share Job