Does anyone care if safety is full of overtitled idiots?

Seriously people so what if the safety people have 800 doing nothing but farming out adverse events to a CRO to process. As long as we have a lot of people doing nothing the FDA will leave us alone. We can always say we have the worlds largest safety department per drug and that doesnt include the headcount we pay for the cros and the fda will say great job

 

Its not that no one cares, its that no one knows how a good safety department looks like. People in the company who havent worked anywhere else like senior management dont realize that 100 people per drug is not the norm and that mds in other companies cover more than one drug each. Here we have 10mds per drug. Its silly and leads to more rounds of review by idiots. In other companies safety hires licensed physicians. We dont have many and the ones we do are the rejects from development. PE and his idiots go around waving a flag about a new environment but the problem is that department is the worst mentally equipped group to adjust to the environment. Most have done safety for a million years with their heads in the sand. Making everyone an ED doesnt help. He needs to hire ED quality people. Given the awful reputation of the deparmtnet, there is no chance we will ever hire any talent.

 

FACTS:

1. About 20 docs in the safety department (if that)... (note to previous poster: I once caught a fish "this big").

2. The docs cover multiple drugs in the clinical trial setting. One Safety Officer per marketed drug.

3. Safety doesn't have any docs from development. Safety wouldn't take any, even at half price. They are simply not qualified.

It is interesting that so many are so intimidated by drug safety professionals. Is it because you can't "fake it" like you can elsewhere in the company... interesting.

Let's see if we get an intelligent, coherent reply. (rather than raving babbles from the misguided and misinformed)

 

OMG another safety troll trying to justify the over staffed department. How many drugs, how many "mds"

Layers and layers of stupid

Does anyone doubt this outside of safety, no.

 

I had the Amgen "Safety Department" experience and it was a JOKE. Had to get out of there-fortunately the Transition Package came just in time. GOOD LUCK

 

Does anyone who knows anything about drug development have any commentary?

 

Our safety department is totally broken and they really are stupid idiots. All of them. Not one competent person. And the overstaffing is true and there are too many "safety docs" per drug. Other companies use one doctor for multiple marketed drug. I don't know why it is different here.

It seems that Roger's strategy was to hire week people so he would look good. The other benefit is that stupid people won't find any safety issues if there are any. However, what Roger and Paul did not calculate was that they would be so stupid they would say there were issues when there were not. Doing 20 million patients studies for dmab is beyond idiocy. More headcount more cost. It wont matter how much we sell, because safety will find ways to increase costs through more headcount, redundant functions and outsource the bread and butter work

 

Wow... an interesting, albeit misguided post. Perhaps, the author needs to up his/her meds and/or is suffering from a side effect of one of his/her meds. Hard to say with just a rambling, tangential posting.

Given the troubling signs of instability, I suggest that readers of this thread hold out for some actual FACTS from a more knowledgeable (employed?) individual with some productive insights.

FACTS:
1. You would never want a single doc overseeing multiple marketing drugs... there is way too much information to review and regulatory requirements / obligations to meet.
2. I would seriously question any company that had only one doc overseeing multiple drugs...

Enjoy the three-day weekend!

 

Seriously folks, does anyone doubt we have the most broken incompetent safety department in industry? I thought so. Please, you safety troll GSOs go crawl back into your hole. It's true we have an overstaffed and overtitled department. It's laughable that any of you have the audacity to show up on campus or even on this board.

Everyone knows safety is broken at Amgen. Even the FDA does.