Lead Post Market Surveillance Specialist

We Make Life More Rewarding and Dignified

Location: Libertyville
Department: Quality

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. This individual must be onsite in Libertyville, IL a minimum of 3 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 mitigating risks associated with post-market surveillance findings.
• Other duties as needed or required.

Requirements:

• Number of Overall Years Necessary: 8-12 years
• Minimum 8 years PMS experience including progressive responsibilities including training, problem solving, report generation, and complaint management
• Bachelor's degree in medical field and 8+ years of industry experience
  
  
  
  • ASQ CQE or CQA preferred but not required
  
  
  
  
• 5 years Clinical Experience
• Knowledge of ISO 13485, 21CFR part 820, EU MDR, MEDDEV, Health Canada, and other international regulations for the medical device industry
• Must exhibit excellent communication skills - verbal and written
• Experience with Microsoft Office suite
• Must be goal and result oriented and have a proven record of success
• Demonstrated problem solving skills and implementation of new processes
• Must have strong organizational and time management skills
• Possess the ability to work under pressure and exhibit multi-tasking capabilities
• Self-motivated and self-directed
• Positive attitude

Specialized Skills/Technical Knowledge:

• Strong interpersonal and decision-making skills
• Strong analytical and problem-solving skills
• Requires strong understanding of global regulatory requirements for PMS.
• Understands medical terminology.
• Ability to interpret and communicate complex clinical information to diverse stakeholders
• Must have manual dexterity (use of mouse, keyboard) - to type and enter data into a computer
• Must be able to sit for prolonged periods of time (6-8 hours per day)
• Must be able to stand for significant periods of time (3-4 hours per day)
• Must be able to handle multiple prolonged telephone conversations
• Ability to travel and perform customer visits

#LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $91,000 - $129,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34983