PMS, Vigilance and Complaint Handling Interview Questions and Answers

Post-market roles, such as PMS specialist, vigilance officer and complaints analyst, are growing as regulators scrutinise real-world performance. Interviews focus on judgement under time pressure: is this reportable, what is the root cause and who must be told? This guide has 8 model questions and three case studies with ideal answers.

What interviewers want to hear

They want a clear, repeatable decision process, calm prioritisation, accurate use of reporting timelines and a link between post-market data and the risk file. Revise post-market surveillance and complaint handling first.

Eight common questions with model answers

1. What is the difference between a complaint, an adverse event and a serious incident?

Model answer: “A complaint is any communication alleging a deficiency in a released device. An adverse event is an unwanted outcome associated with the device. In the EU, a serious incident is one that led, might have led or might lead to death, serious deterioration in health or a serious public health threat. Not every complaint is an adverse event, but each must be assessed.”

2. What are the US reporting timelines for deaths and serious injuries?

Model answer: “Under 21 CFR Part 803, manufacturers report deaths, serious injuries and certain malfunctions within 30 calendar days of becoming aware, and within 5 work days for events needing remedial action to prevent unreasonable risk of substantial harm. I would verify current rules on FDA’s website before writing them into a procedure.”

3. And in the EU?

Model answer: “The general limit for serious incidents is 15 days from awareness, shorter for a serious public health threat and for death or unanticipated serious deterioration. Trend reports for statistically significant increases are required under Article 88.”

4. What are the documents of EU post-market surveillance?

Model answer: “A PMS plan for all devices, a PMS report for Class I, and a PSUR for Classes IIa, IIb and III, updated at least annually for IIb and III.”

5. How do you do trend analysis?

Model answer: “Group complaints by product, failure mode and period, normalise by units sold or in use, compare with the expected rate from the risk file and set thresholds that trigger action. Trends are reviewed in management review.”

6. When is a field safety corrective action needed?

Model answer: “When data shows an unacceptable risk in devices already on the market, for example a failure that can cause serious harm and cannot be controlled by existing measures. Decisions are based on a health hazard evaluation and involve regulators and customers.”

7. How does PMS data feed the risk file?

Model answer: “I compare real-world occurrence and severity with the risk estimates. If they differ, I update the risk analysis, review the benefit-risk conclusion and propose design, labeling or process changes.”

8. Tell me about a time you escalated a safety concern.

Model answer (STAR): “Three complaints in a month described a device overheating (situation). I was the complaint owner (task). I flagged a potential serious injury, started a reportability assessment the same day, requested returns, and informed the quality and regulatory leads (action). The investigation found a component defect, a field action followed, and the report was filed on time (result).”

Case study 1: the vague complaint

Scenario: A distributor emails ‘the device stopped working and the patient had to be treated’ with no details.

Ideal answer: “Treat it as potentially reportable from day one. Log it with the date of awareness, ask for specifics urgently, such as device identifiers, what treatment, patient outcome and whether the device is available. I would start the reportability clock conservatively, escalate to the vigilance owner and document every attempt to get information. I would not wait for full facts before assessing.”

Case study 2: malfunction with no harm

Scenario: A pump alarm failed during a test, but no patient was affected.

Ideal answer: “I would assess whether the malfunction could cause or contribute to death or serious injury if it recurred. For FDA reporting a malfunction can be reportable if it would be likely to cause or contribute to such an outcome. In the EU the ‘might have led’ wording is relevant. I would record the decision with reasoning, investigate the cause and consider CAPA and a risk file update, even if no report is made.”

Case study 3: rising trend within the expected rate

Scenario: Complaints about a sensor have doubled in a quarter but remain under the rate predicted in the risk file.

Ideal answer: “Staying below the predicted rate is reassuring but a doubling is still a signal. I would check whether the change is statistically significant, look for patterns by lot, site or user group, and assess whether severity is changing. I would investigate, set a closer monitoring interval and decide if a trend report is required under local rules. I would document the justification either way.”

Mistakes to avoid

• Waiting for certainty before escalating.
• Quoting timelines without saying you would confirm the current rules.
• Treating each complaint in isolation.

Frequently asked questions

Do I need clinical knowledge for PMS roles?

It helps, but a structured approach to assessing harm and working with clinical experts matters more.

Are PMS and pharmacovigilance the same?

They are related disciplines with different rules. See our pharmacovigilance course for the drug and biologic side.

How can I show experience if I have not filed a report?

Describe how you would assess one, using a public example from regulator databases, and show a clear decision process.

Reporting timelines differ by market and change. Verify against current regulations.

Talk to the AptSkill team

Preparing for a post-market or vigilance interview? Send us a message.