The 21 Things I’ve learned (the hard way) while working on important documents as a medical reviewer @ Aggregate reports (PBRERs, PSURs and PADERs)

Does your work involve working with financially/legally or in any other way important documents? Pls read on for a few real life insights (Do’s and Don’ts) I got with regards to documents after 2.5 years career so far as a medical doctor reviewing aggregate drug safety reports by many trial and mostly many more errors!

WHERE I AM COMING FROM?

I work in Pharmacovigilance or drug safety industry. As a medical reviewer of aggregate reports (PSUR/ADCO/PADERs); my work can basically be summed up as, analyse case reports describing potential side effects experienced by patients and study all possible factors that can cause the experienced/reported Adverse Events (AEs/Side effects). Decide if the company drug (for which the report is being written) caused the aforementioned events or some other drugs taken by the patients or some underlying medical conditions have caused these events? In addition, to what degree the events can be attributed to our drug (relative attribution). Most important part of analysis is; how many cases were reported in which only company/MAH drug was responsible alone and if these cases show a pattern previously unknown by comparing the same w known data the company provides us. After analysis of all such cases provided to me, I have to evaluate the data, do the trend analysis by comparing cases related to AEs during the report time period with the cumulative time period (period during which company marketed the drug) and identify trends or any new or significant information relevant to drug that can potentially alter benefit – risk ratio for the company drug. After preparing this whole document, we submit the same to Pharma Company and they get their licenses to sell the drug or get to renew such license once the regulatory authority approves them based on such safety reports.

Now you can imagine, for the Pharma companies, such documents are very important. The?more sound?such aggregate report is, the better it is for the company since a lot is at stake for them (R and D, production and surveillance of drugs costs millions and billions of $$$ to them).?I have described my work so that you can understand where I am coming from! There are literally 5-7-10 people, hired just to review this same report we prepare at multiple levels (starting from my company teammates- report author,?internal QCer, my managers, client side people, regulatory authorities people and so on)… Their work is to find faults in our reports (it’s a highly regulated industry) and they get paid (handsomely) to do that. Naturally, even minor mistakes (ranging from typos, spelling, grammar, formatting, and spacing) to major mistakes (forgetting to write a detail, considering some factors or drugs affecting the AEs in evaluations or numerical errors) matter; oh boy, do they matter a lot! There are strict guidelines to follow within stringent timelines. Timely submission is equally or even more important than quality of the report. So have to give importance to both aspects while preparing reports. Mistakes made by doctors are obviously considered more critical and serious and can severely affect the quality score/parameters set by managers, clients or regulatory authorities.

In aggregate reports, after allocation of reports, medics get time of 2-5 workdays (mostly) to evaluate 1000s of cases, 100s or even 1000s of literature reports and provide our trend analysis, benefit-risk analysis and review medical sections. Naturally, you can understand the pressure we usually are in with a full cricket team hired just to find our mistakes :-)

So basically we work on a single report document for days at once. I learn by mistakes, mine and other peoples’, and adapt to new standards, new demands of the team, managers, clients and regulatory authorities.?In my 2.5 years in this line (9-Jan-2017 till present, this being written on 18-Jun-2019), I’ve written and reviewed 200+ such reports with fair share of mistakes and learned from every single of these mistakes coz that’s the only way! Based on this experience, I’ve derived some 20+ Do’s and don’ts which are equally applicable to other professions like lawyers, CAs, engineers and so on.. Hence, I thought I’d write about them.

Do’s and don’ts for high importance documents:

1. Learn from mistakes: (yours and of your colleagues') coz mistakes make the best teachers! Don’t let any mistake go without analysing and learning something off of them!
2. Invest time in learning: MS Office esp. Excel and MS word since they do make things a lot easier although time-intensive in the initial phases.
3. Develop your Critical Thinking and Analytical skills: Do the self-audits of your own work and draft. Think of the worst kind of fatal errors and cases; imagine regulatory authority asking questions about what you’ve just written and your, your team/manager’s company and livelihood on the line based upon your answer.
4. Be pro-active: Talk with the team, the QCers the managers and experienced people, share your thought process and learn theirs since in my experience teammates prove to be superb teachers in quality review of our works!
5. Proactively plan everything: their impression of the source data, and their assumptions on complexity of the data you will be working on, the dates you need to keep in mind while working on the data. Ideal time to share, the time the team will need after you send your draft, time for your own review, count it all and plan accordingly. Also consider some time for self-review of the final draft prior to sharing it further and be prepared to prepond the report if the need arises for the same.
6. Troubleshoot for your team: Go to team lead/ manager and author/QCer and ask them about the time they will need, how this upcoming report is different for them, their insights on this report and data, explain sailent features of this upcoming project or report from your experience and expertise. Reveal your weaknesses and fears esp to QCer, questions by whom will only make your work more sound! Make yourself approachable and be an effective listener. Your colleagues must feel that they're being heard and their insights are useful, doing so will open communication channels and can be very very important in improving your work quality.
7. Liaise with the team?member dealing with the client: you are preparing your report for; since ultimately you need to be aware of the timelines and expectations of this person! Transparency with this person will take away many future problems and avert disasters which can happen due to lack of effective communication.
8. Develop your Decision-making skills: Consider all options, rule out common pitfalls of the decisions. Imagine each and every question that they can ask based on this last (and every) sentence you just wrote (they will ask) or the minor/major decision you’ve made so far. And answer those questions, add and modify the sentence, make it fool-proof.
9. Highlight all your doubts in the draft: Write the questions you have in comment boxes of MS word. Colour-code them. Do it preferably in real time while working on that section particularly and discuss w concerned persons who can provide their informed insights ideally the same day. Specifically mention what action you need to take on the highlighted part (if any) later. If the highlight is for QCer/author or any specific stakeholder, mention them clearly followed by the action they’re supposed to take on that part.
10. Keep saving your work: every 15-20 mins manually apart from auto-save. I’ve once lost whole report coz MS word crashed at the eleventh hour and had to work 5 more hours just to get the report done on time, my productivity took a full day hit that day!
11. At the end of the day, Save the draft with date: and?new name for that day eg. Aspirin PADER 18 Jun 2019 EOD and email your work on that draft so far to yourself on one on one basis. One of my colleague travelled in rain and his wet laptop crashed, taking 4 days-worth of draft with it! We can also use MS OneNote as an option for back up so that if laptop crashes, we can get the work restore with the help of IT department in no time on the new system J
12. If possible, Maintain a Personal Query Tracker: write your queries, answers, client or QC comments you received and any updated rules or conventions in it, to be up to date and to defend your due diligence on your professional work.
13. Check Completeness of the Source Data: as well as that of your own work and data you’re sending forward in the workflow.
14. DO not compromise with the argument: behind your decision. If you claim this drug caused the given AE for example; think of at least 3 evidences you can defend your decision with using standard scientific strong referneces such as PubMed or standard textbook etc. Already take it for granted that you'll be defending these same words using these 3 decision points with rock-solid standard universal defences any client, manager or regulatory HAS to accept without a slight whimper.
15. Do not add data you cannot defend later: on even though temptation for the same may be very high sometimes, we all have cognitive bias in such works and cannot afford to let such bias cloud our judgment.
16. Constantly learn new things, discuss: update your knowledge, teach and share things you’ve learned working on this last report with your team, have some discussion after each and every report you send and make the QCer aware of the potential weak links of the report you just wrote, ask to be questioned by the in-house QCer who is your biggest well wisher while working on such documents.
17. Invest time and money in learning new things, skills, courses and discussions with teams; with ever increasing demands for work from manager, client and regulatory, you cannot go on with the same knowledge base you have now; after 6 months! Convictions and conventions change, experiences add up and mistakes are made; the lessons learned from all this have to be adapted in your next report or work without failing! There's a famous business book called 'What got you here won't get you there' ; which exactly applies in this context. Expansion of knowledge base apart from such efforts by manager/team are essential for maintaining and improving our quality over time!
18. Create your own frequently used resources, performa, pre-written sentences and use them as frequently as you can by cutomosing them for this new report. Not having to type??them saves a lot of time and agony.
19. Divide the work in 5-6 equal shares during the workday. Decide your target (ie 40 cases a day for example) and stick??to it?no matter what.
20. Find your Einstein Window! So, this is a very interesting concept I learned from a LinkedIn learning course I watched about Time management! It is the time period (window) during which we can get most things done with great quality! Its called the Einstein window and it can be considered as the most fruitful or productive time of the day. Try maximizing the work done during this time. Defend this window and use only for the most high priority work during the day. Switch off the mobile during this time, ask your colleagues and even manager that you will be busy in this time and youll get back to them after that time. As per the very often talked about 80:20 rule, you do your most effective 80% work during this 20% time period and you need to utilize this time for your and your manager’s livelihood!
21. Totally own your work: This is probably the most important thing one can do as a professional. Responsibility, ownership and accountability would take anyone far and higher professionally. Responsibility is your internal standards for the output you provide, accountability is to your teammates, manager and organization and work ownership is the supreme key to professionalism as per LinkedIn Learning course! If the draft you send by your hand under your E-mail account, that is your work; end of discussion! Period! What you send under your name and E-mail?is the professionally you! Faulty source data?? Incomplete data? Unreasonable source data?compounded by the?dictator as?your manager or nagging irritating clients with superiority complex?? Boo freakin hoo; coz all of that just doesn't matter once that 'send' button is pressed in MS outlook! You have allocated data, time and team including your superiors from your company to make the most of them. Once send is pressed; everything after that is mere afterthoughts. They just dont' matter other than for learning for the subsequent work!?????????????

So, these are some 21 important lessons I’ve learned in 30 months of working with highly important medical documents! They have become my blueprints for work, work-ethics?and second nature in everything that I do now, due to sheer repetition! Hope my article provided some food for thought to you. Please tell me your experiences, solutions, insights?and esp. mistakes/lessons from these mistakes you have learned in the comment too?:-)