Lead Post Market Surveillance Specialist

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Date:
Jan 28, 2026

Location(s):
Libertyville, IL, US,

Company:
Hollister Incorporated

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Summary:

The Lead PMS Specialist ensures the safety and regulatory compliance of our products after they have been released to the market. The main responsibilities include leading post market risk assessments, the field action process, reporting on post-market product performance and adverse events, and authoring post market surveillance reports. The Lead PMS Specialist will also collaborate with cross-functional teams to address any issues identified and contribute to continuous improvement initiatives.

Hollister Incorporated operates in a hybrid work environment. Beginning May 4, individual must be onsite in Libertyville, IL a minimum of 4 days per week.

Responsibilities:

Post Market Risk Assessment (PMRA) and Field Actions:

• Lead and coordinate post market risk assessments to evaluate the impact of post-market events on patient safety and product effectiveness.
• Prepare comprehensive reports summarizing clinical risks, trends, and potential implications for product safety.
• Leads assessment of PMRAs and able to process, evaluate, and recommend PMRAs for field actions according to regulations and procedures, as applicable.
• Collaborate with medical professionals to assess the clinical significance of adverse events and identify potential risks.
• Leads Field Actions according to procedure and regulations. Which includes Field Action plan and log, developing customer communication, managing consignee list and tracking response forms, and notification to Regulatory Authorities according to regulations as applicable.

Surveillance and Analysis:

• Monitor and analyze post-market data, including customer complaints, adverse events, proactive PMS surveys/product evaluations and product performance metrics.
• Lead and oversee complex complaint investigations, including those related to serious incidents and potential recalls
• Assist with the review and processing of complaints in a timely manner according to regulations
• Help provide high level customer support and serves as a liaison and subject matter expert between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints.

Regulatory Compliance:

• Ensure compliance with relevant regulatory requirements and standards related to post-market surveillance.
• Stay abreast of regulatory changes and updates, incorporating them into the post-market surveillance process.
• Proactively prepares for audit readiness. Provides support during internal and external audits. Provide support for requests that come during audit and represents complaint team in front of the auditors.

Reporting:

• Acts as the SME for adverse event/vigilance reporting.
• Responsible for adverse event/vigilance assessment, decision trees and reporting to the regulatory authorities as well as training other team members of these job duties
• Acts as adverse event/vigilance pre submission reviewer.
• Authors post-market surveillance reports as required [PMS plans and Reports, Periodic Safety Update Reports (PSUR)],
• Collaborate with Global Clinical Affairs to develop Post Market Clinical Follow-up (PMCF) plans, studies and reports, as applicable.
• Communicate findings and recommendations to internal stakeholders, including management.

Cross-functional Collaboration:

• Collaborate with other departments such as Clinical Affairs, R&D, Quality Assurance, and Regulatory Affairs to address identified issues and potential clinical risks. Encourage implementation of corrective and preventive actions.
• Collaborate with Global Market Access, Global Marketing Organization, Global Clinical Affairs to develop proactive post market surveillance surveys and evaluations.
• Participate in cross-functional teams to provide post-market surveillance expertise in product development and improvement efforts.

Trend Analysis and

Risk Management:

• Identify and analyze trends in post-market data to proactively address potential issues.
• Contribute to risk management activities by assessing and…