Automation. Robotic Process & Cognitive Automation. Artificial Intelligence... Yes, you are reading it right: this is a job in Drug Safety.

We look technology in the eye:

• Our mother company, Labcorp was named to Fast Company magazine's list of 2021 Most Innovative Companies for its leadership in scientific innovation in the fight against COVID-19.

• At the same time, Covance, was recognized with the 2020 Global CRO Company of the Year Award by Frost & Sullivan for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.

We are embracing cloud-based solutions, mobile apps and technology for big data analytics as a key part of our Drug Safety & PV strategy.

THE JOB

This is a full time, remote job, to be based in any of these countries: UK, Czech Republic, Poland, Bulgaria, Romania, Ukraine, Spain or Italy.

On a normal day, you will find yourself providing leadership to the PV & Drug Safety portion of both global ph I-III clinical & postmarketing studies, ensuring that communications and processes are harmonized and helping your clients to ensure the study aligns with all the safety regulations.

You will own your projects and will have client facing responsibilities right from the start, being heavily involved with the initial proposal stage (defining and negotiating contractual obligations and timelines) or playing a pivotal role at BID meetings or in the oversight of the Start-up phase.

You will develop the Safety Management and Reconciliation Plans and contribute to the creation and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.

We will trust you the oversight of:

• Timely pharmacovigilance reports, i.e. ICSR of SAEs

• The receipt and processing of all AE reports reported (entry of safety data onto AE databases & trackers, review of AE for completeness and appropriateness for expedited reporting, patient narratives, etc)

• The processing & management of expedited safety reports ESRs and the EudraVigilance activities for your projects

• Signal detection and trend/ pattern recognition

You will monitor your team´s project deliverables regarding contract assumptions, identifying out of scope work or potential to run over budget.

You will be the financial authority of your projects, including budget oversight, creation of change orders and negotiation with clients.

We will expect you to lead the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients, and the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.

WHAT MAKE THIS JOB SPECIAL?

Unlike other CROs, this is not an operational job , or a hybrid between PM and Ops: your main focus will be leading, overseeing and client management.

You will work on global studies, managing all regions , and acting as the main point of contact representing the Drug Safety function.

This wide scope defines your team: internationally distributed , up to 15 people -if several continents enrolled, you will be supported by Regional Safety Leaders.

An important part of your day to day will be you providing support and training in all aspects of case-handling and adverse event reporting for your team, acting as a mentor to less experienced colleagues

Our employees make a difference in the lives of millions of people... and you will too.

Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career -apply now!

EMEA AND THE SAME JOB REF

#LI-NC1EMEA Remote
Education/Qualifications:
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

EudraVigilance Certification preferred
Experience:
IS THIS YOU?

As a base, we need you to bring an extensive background processing AE/SAE reports, generating narratives, queries, working within safety databases, and regulatory submissions.

MUST: PM/ Lead capacity at Drug Safety. Experience at an international CRO with a combination of Ph I-III clinical trials and postmarketing studies.

Additionally:

• Project Documents creation (Data Management Plan...)
• Experience laising with authorities for reports
• DataBases
• Ideal: Project management

It´s very important that you have on-going reporting responsibilities and direct interaction with clients in your current role.

Demonstrate critical thinking skills: analyze data and make assumptions, speak up in front of client.

Excellent team player, ideally you bring Team Leading expertise.