Ctsa Manager Interview

Can you describe your experience managing Pharmacovigilance vendors?

My experience at Johnson & Johnson is a local safety officer is where I managed most of the pharmacovigilance when this throughout my career I was at a local 50 officer making sure all that all the documentation in terms of the contractors or the vendors are in line with our standard onboarding process so this involved having a Safety Management plan in place and a quality management plan in place along with the communication plan I was also involved in making sure that there is a continuous one-on-one or with the team to team interactions with the vendor which which meant weekly and a monthly update meeting I was also responsible for making sure that our compliance and quality is in check so on a weekly basis we would meet with the vendor to assess the quality of a specific week or a week prior and then understand the the on time and be late submissions of cases and what was the reason and try and get a root cause analysis and papa in place for a deficiency made a submission slate I was also responsible for making sure that our vendors are compliant on their trainings they are compliant in terms of onboarding new Associates and making sure that they understand the policies of the company which was my company

Your answer provides a solid overview of your experience managing Pharmacovigilance vendors, highlighting key responsibilities and processes. You mention your role at Johnson & Johnson as a local safety officer and emphasize important activities such as maintaining safety and quality management plans, conducting regular meetings with vendors, and ensuring compliance with training and onboarding.

However, your response could be improved in a few areas:

1. Structure: Organizing your answer into clearer segments (e.g., overview of role, specific responsibilities, and outcomes) would enhance clarity.

2. Specific Examples: Providing a concrete example or a specific challenge you faced when managing vendors and how you overcame it would give depth to your answer.

3. Results or Impact: Mentioning the positive outcomes of your vendor management—like reduced compliance issues, improved submission timelines, or enhanced collaboration—would strengthen your response.

4. Terminology & Clarity: Ensure that terms like "local 50 officer" are clear and correctly stated; it seems like this might be a typo.

Overall, your answer demonstrates relevant experience but could be more concise and impactful.

Rating: 3.5/5

By refining the structure, adding specific examples, and emphasizing the results of your efforts, you can present a more compelling narrative in future interviews.

How do you ensure compliance with corporate policies and local regulations in a Pharmacovigilance setting?

I would like to move on I don't know the answer to this question

Your answer of "I would like to move on, I don't know the answer to this question" is not appropriate for an interview setting, particularly for a managerial role in Pharmaceutical Management where compliance is crucial. This response indicates a lack of preparation and knowledge about a fundamental aspect of the position.

In pharmacovigilance, ensuring compliance with corporate policies and local regulations involves several key activities. These include establishing a framework for standard operating procedures (SOPs), conducting regular training sessions for staff to keep them updated on policies and regulations, and implementing a robust reporting system for adverse events. Furthermore, regular audits and quality control measures can help identify compliance gaps, while fostering a culture of transparency and accountability ensures everyone understands their responsibilities.

To improve your answer, you could express a willingness to learn more about compliance, mention potential strategies you might implement such as aligning with regulatory guidelines, and emphasize the importance of continuous education in pharmacovigilance.

Rating your answer: 1/5. It does not provide any relevant information or demonstrate your understanding of the topic. By acknowledging the gap in your knowledge while showing eagerness to learn and apply future strategies, you can transform your response into a more constructive one.

Describe a time when you had to train staff on adverse event handling procedures. What was your approach?

In my career working as a local safety office at J&J and working at Shoppers Drug Mart specialty Health Network I have conducted online face to face and over the telephone Edwards event report training for the staff and J&J I was responsible for any new onboarding staff training related to adverse event reporting so a human resources team would send an email out to the PB team on on a weekly basis in terms of any new addition to the company this included all the corporate stuff as well as the sales team so on on I want to SLA or everything the PV team was once we received the notification of a new new associate joining the company we would have five working days to act on on act on this and make sure that trainings are complete so I would coordinate this bit the hiring manager as well as the new staff we set up a time as per the requirements as per the suitability of the candidate if they are corporate employees and if their office based I I would set up a training room and conduct the training I would if there are more than one Associates I would try and set up a time with suits for suits all the or as many as many new joiners as possible so that it becomes more effective and time we save time at J&J I was also responsible for the yearly refresher training so whenever on on yearly basis we would conduct three sessions for the corporate staff to come conduct that training as for this utility and suitability and availability of the staff for the corporate office and for the for the sales team on on a yearly basis they would call all the sales team to the head office to conduct their marketing related trainings as well as programs or or an achievement related celebrations we would book half an hour during that time to conduct this training so this is what I did in terms of handling adverse event procedures my Approach was always about a making sure they understand making sure the employees understand the importance of PV department and reporting of adverse event B I was always willing to arrange a schedule which is suitable to most of our staff and it is it fits into the training management plan of the department as well so I feel giving everyone flexibility of of attending the training making sure that you are approachable and and serious about adverse event reporting so that's why that that was my Approach

Your answer provides a detailed account of your experience training staff on adverse event handling procedures, which is relevant to the question. You outlined specific actions, such as coordinating with HR for onboarding and arranging training sessions, demonstrating your organizational skills. However, there are areas for improvement to enhance clarity and conciseness.

Strengths:
1. Relevant Experience: You highlighted your roles at J&J and Shoppers Drug Mart, which lend credibility to your answer.
2. Structured Approach: You detailed your methods for training, including coordinating schedules and providing refresher sessions.

Areas for Improvement:
1. Clarity: Your response can be streamlined. Break down your answer into clear sections: your role, approach, and results. This will make it easier for the interviewer to follow.
2. Specific Examples: Incorporate a brief example of a challenge you faced during training and how you overcame it. This could provide insight into your problem-solving skills.
3. Emphasize Impact: Discuss the outcomes of your training—how it improved reporting compliance or staff knowledge can add to your effectiveness.

Improved Answer Example:
"In my roles at J&J and Shoppers Drug Mart, I led training sessions on adverse event reporting procedures. I coordinated with HR to ensure all new hires were trained within five days of their start date. For effective training, I customized schedules to fit staff availability. I conducted both online and in-person sessions, making sure to accommodate corporate employees and sales teams during their annual meet-ups.

I emphasized the importance of pharmacovigilance to ensure compliance and fostered an open environment for questions. By doing this, I noticed increased reporting rates post-training, signaling improved understanding.

Overall, my structured approach, flexibility, and emphasis on the importance of the PV department resulted in a deeper staff comprehension of adverse event handling."

Rating: 3.5/5

This revised format provides a clearer picture of your experience while allowing for a more compelling narrative.