Director Pharmacovigilance & Patient Safety - Pharmacoepidemiologic studies
- Experience Level
- Senior Management
Do you want to watch patient safety change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 15,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Director, PV and Patient Safety, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As the Director of Pharmacovigilance and Patient Safety (PVS) you will have responsibility for the development and delivery of strategies and the analysis of regulatory-agency required and MAH-initiated pharmacoepidemiological studies such as PASS, PAES, PMR, or DUS.
In the process of signal management you will develop and lead signal detection strategies and approaches to evaluate the causality of drug-event pairs.
You will support the design of risk minimization measures for RMPs and REMSs and evaluate their efficiency in support of clinical development, regulatory filings, and post marketing requirements.
The development of strategies for systematic literature reviews and meta-analyses and their conduct will also be part of your duties.
Primary responsibilities include but are not limited to:
- Working with pharmacoepidemiology study design and execution
- Integrating RWD from different sources
- Collecting and interpreting PROs and patient or HCP preferences
- Understanding the global RW database landscape, including access to data
Location: Europe remote, travel requirements up to 10%
What is important to bring?
- An advanced academic or professional degree (PhD, MD, PharmD),
additional postgraduate education in epidemiology (e.g., a postgraduate diploma or MPH) would be a plus
- Substantial experience in the pharmaceutical industry with at least five years of experience in a leadership position in pharmacovigilance/pharmacoepidemiology
- Profound knowledge of regulatory requirements for human drugs, biologics, and/or devices
- Experience in change management
- Proven history of successful interaction with internal and external stakeholders
- Effective written and oral communication and presentation skills
- Reads, writes, and speaks fluent English
- Substantial experience in project leadership
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
For more information please visit our website: www.prahs.com