Job Title : Manager of our Drug Safety Physicians Team
Location : 2800 Mechelen
Company : SGS
Salary :
Open Date : 2023-03-04
Close Date : 2023-07-04

Company Description

At SGS, you can choose!

First of all, out of our various vacancies.
However, SGS also gives you another choice.
Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. SGS Life Sciences has also expertise in the quality control of pharmaceuticals.

• You have a medical degree? Check!
• You want to use your medical knowledge in a different context? Check!
• You want to contribute to the fascinating world of Clinical Research? Check!

In that case we have a challenge for you as
MANAGER of our DRUG SAFETY PHYSICIANS team

Job Description

Your challenge in this role?!

To organise, follow up and maintain oversight on the Medical Projects performed by the team of Drug Safety Physicians (DSPs). Act also as Medical Monitor/ Medical Reviewer for assigned projects. Detailed list of tasks include:

Overview of Medical projects

• Evaluate the work planning, the required medical expertise and project organization (deadlines, allocated resources, back-up system) for new projects
• Ensure that DSPs received all needed information, tools, documents and training to perform the project according to sponsor’s expectations
• Ensure adherence to applicable standards, SOPs, and agreements with sponsors and/or MAH
• Ensure adherence to project timelines
• Evaluate project performance with the allocated DSPs on ongoing basis
• Discuss with DSPs and/or sponsor/MAH (potential) issues and follow up until resolution
• Ensure correct documentation of the performed tasks and filing

Training and Coaching

• Ensure organization of training, introduction or feedback session(s) (face-to-face meetings or telecons/web conferences) with DSPs (and sponsor if needed) at the start or during the project
• Ensure sharing of working practices and experience among the DSP team
• Give guidance to DSPs for proper execution of the work
• Provide feedback to Head Medical Safety & Regulatory with respect to performances
• Stimulate DSP to gain more medical expertise in therapeutic areas of interest for the projects

Budget Control & Business development

• Responsible for the preparation of new budget proposals and maintain budget control for the ongoing projects
• Be available as customer liaison to support business development and client meetings

Medical monitoring/ reviewing:.

• 
  Medical review of assigned clinical trial protocols and medical input in study documents
• Preparation of medical monitoring plan
• Medical input to internal parties (Feasibility, Clinical Operations, Data management, Statistics, Medical writing)
• Answering trial/protocol related questions from investigators
• Act as main medical contact person for study/ project team
• Medical Review of clinical data from eCRF/CRF (medical consistency of clinical and safety data, identification of any medical issue, medical review of coding)
• Medical review of clinical study report (CSR)
• Open and regular communication with sponsors
• Medical Review of clinical and post marketing safety data (Individual case safety reports or aggregate safety reports)
• Medical review of literature results in view of benefit/risk reports
• Able to summarize medical/scientific reports for inclusion in benefit/risk reports

Qualifications

What do you need to be successful?

• Medical Doctor (MD)
• At least 4 years of experience in a pharmaceutical industry or CRO
  in a medical position
• Quality minded; Eye for detail and being able to make distinction between main and side issues
• Overall organizational skills
• Coaching skills
• Communication skills
• Problem solving mind
• Respecting budgets and timelines
• Being able to prioritise issues according to importance
• Languages: fluent English

Additional Information

Were you already considering a next step further in your career?!
Maybe this could be your next step.

In this function you can take responsibility and ownership, combined with real teamwork, where you can make a difference!

Do you want to be part of this?
We are looking forward to hearing from you!
Still have questions?

Heidi Aerts can give you more details about the job. Send her an e-mail at [email protected]

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