- Experience: 2-5 years
- Contract - 1 Year
- Location: Pune
Job Description - Post Market Surveillance (PMS) Analyst (Contractual)
Position Title: Post Market Surveillance (PMS) Analyst (Contractual)
Location: Pune, India
Department: Quality & Regulatory Affairs / Post Market Surveillance
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Contract Type: Fixed-Term ContractPosition Overview
The PMS Analyst will support Post Market Surveillance activities for medical devices in compliance with global regulatory requirements and Siemens Healthineers quality procedures. The role will involve monitoring, analyzing, and evaluating post-market data to identify safety signals, support risk management activities, and contribute to regulatory compliance and patient safety initiatives.
This is an excellent opportunity for professionals with experience in Quality, Regulatory Affairs, Vigilance, Complaint Handling, or Post Market Surveillance within the medical device or healthcare industry.
Key Responsibilities
Post Market Surveillance Activities
- Review, analyze, and trend post-market data from multiple sources including complaints, sales, adverse events, literature, CAPA, customer feedback, and regulatory databases.
- Support the preparation and maintenance of PMS documentation, including PMS Plans, PMS Reports, Periodic Safety Update Reports (PSURs) and trend reports
- Perform data analysis to identify potential safety signals and emerging risks.
- Support complaint trending and escalation activities in accordance with internal procedures
- Collaborate with Risk Management, Regulatory Affairs, Quality Assurance, Clinical Affairs, and Product Experts to assess post-market information.
- Evaluate whether post-market findings impact product risk-benefit profiles.
- Ensure PMS activities comply with applicable regulations and standards, including EU MDR 2017/745, FDA requirements, ISO 13485, Relevant global post-market surveillance regulations
- Support responses to internal and external audits and inspections.
- Generate PMS metrics, dashboards, and trend analyses.
- Maintain accurate and timely documentation within quality management systems.
Required Qualifications
Education
- Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, Biomedical Sciences
Experience
- 1-5 years of experience in Post Market Surveillance, Complaint Handling, Medical Device Vigilance, Regulatory Affairs, Quality Assurance
Technical Knowledge
- Understanding of:
- EU MDR requirements, Risk Management principles (ISO 14971), Quality Management Systems, Complaint handling and vigilance processes, PMS and signal detection methodologies
- Strong data analysis and reporting skills.
- Proficiency in Microsoft Excel, PowerPoint, and quality management systems.
Soft Skills
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Attention to detail and ability to manage multiple priorities.
- Ability to work effectively in a global and cross-functional environment.
Note: This is a contractual position with the possibility of extension based on business requirements and performance.
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