Manager of Our Drug Safety Physicians Team
il y a 1 semaine
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 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).
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, backup 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) (facetoface 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_
- _ Communication_ skills
- _ Problem solving_ mind
- Respecting _budgets and timelines_
- Being able to _prioritise_ issues according to importance
- Languages: _fluent English_
Were you already considering a next step further in your career?
Maybe this could be your next step.
In this function you can take responsi
-
Head of Preclinical Safety Leaders
il y a 1 semaine
Mechelen, Flandre, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) . We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want...
-
Medical Safety Lead
il y a 1 semaine
Mechelen, Flandre, Belgique Hobson Prior Temps pleinSalary:NegotiableJob type:Interim/ContractLocation:Mechelen, BelgiumFunction:PVG & Drug Safety, Drug Safety AuditsPosted:08/04/2024Ref:BBBH2506- Hi I'mTerrah-Leigh, I manage this rolePlease note that to be considered for this role you must have the right to work in this location.Key Responsibilities Oversee global pharmacovigilance activities for...
-
Clinical Development Leader
il y a 1 semaine
Mechelen, Flandre, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) . We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want...
-
Senior Medical Safety Operations Leader
il y a 1 semaine
Mechelen, Flandre, Belgique Oxford Global Resources Temps pleinAre you an expert in Drug Safety and Pharmacovigilance with leadership skills? Do you want to take on the challenge for an interim leadership role within Safety Operations in a dynamic, growing Biotech company? Don't hesitate and apply now Job description The Medical Safety Operations Leader will report to the Head of Medical Safety and will lead all related...
-
Senior Medical Safety Operations Leader
il y a 1 semaine
Mechelen, Flandre, Belgique Oxford Global Resources Temps pleinJob Description: Are you an expert in Drug Safety and Pharmacovigilance with leadership skills? Do you want to take on the challenge for an interim leadership role within Safety Operations in a dynamic, growing Biotech company? Don't hesitate and apply now Role Overview: The Medical Safety Operations Leader will report to the Head of Medical Safety and will...
-
Medical Safety Leader
il y a 1 semaine
Mechelen, Flandre, Belgique Oxford Global Resources Temps pleinMedical Safety Leader: Location:Mechelen Contact:Amandine Planche Job type:Permanent Contact phone: Industry:Pharmaceutical, Life Sciences, Clinical Research, TransportationAs a Medical Safety Leader, you are responsible for global pharmacovigilance activity of dedicated investigational products portfolio, including review and analysis of safety data from...
-
Inside Sales Manager I
il y a 1 semaine
Mechelen, Flandre, Belgique Labcorp Temps pleinLabcorp, a global contract research organization, has worked on all of the top 50 best-selling drugs available today with our clients from leading pharma and agile biotech. Together with our clients, Labcorp transforms today's healthcare challenges into tomorrow's solutions.Labcorp is seeking to hire an Inside Sales Manager I for Early Drug Development...
-
Medical Safety Associate
il y a 1 semaine
Mechelen, Flandre, Belgique SGS Temps pleinCompany DescriptionAs part of the world's leading testing, inspection and certification company, you share the benefits of our stability and growth; secure employment in a financially stable, Swiss-based company; a proud heritage that has been making the world a better, safer place for over 140 years; and a global, multicultural, and multinational...
-
Health Safety
il y a 1 semaine
Mechelen, Flandre, Belgique E Temps pleinE.ON Power Plants Belgium (EPPB) | Permanent | Part or Full timeE.ON Power Plants Belgium BV, a subsidiary of E.ON Energy Projects GmbH, develops, builds, finances and operates decentralised energy generation plants for industrial customers in Belgium and the Netherlands. E.ON Energy Projects GmbH installed more than 1 gigawatt (electrical) of projects...
-
Safety Supervisor
il y a 1 semaine
Mechelen, Flandre, Belgique Group IPS Temps pleinGroup-IPS. Come join us in reshaping the future of Engineering and Architecture Projects.Who are we? IPS is an international company with inhouse engineering and specialized services across Project Management for industries, Automation and Architecture. EPCM expertise, more than 10 countries around the globe but an entrepreneurial and teambuilding...
-
Site Management Associate
il y a 1 semaine
Mechelen, Flandre, Belgique ICON plc Temps pleinICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical and biotechnology organisations.With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and...
-
Assisant Medical Safety
il y a 1 semaine
Mechelen, Flandre, Belgique SGS Temps pleinCompany DescriptionAt 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...
-
Medical Safety Assistant
il y a 1 semaine
Mechelen, Flandre, Belgique SGS Temps pleinCompany DescriptionAt SGS, you can chooseFirst 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...
-
Technical Facilities Coordinator
il y a 1 semaine
Mechelen, Flandre, Belgique Labcorp Temps pleinGet ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp Drug Development, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be...
-
Study Coordinator Data Management
il y a 1 semaine
Mechelen, Flandre, Belgique Labcorp Temps pleinGet ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp Drug Development, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be...
-
Regional Study Coordinator
il y a 1 semaine
Mechelen, Flandre, Belgique Labcorp Temps pleinGet ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp Drug Development, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be...
-
Team Manager
il y a 1 semaine
Mechelen, Flandre, Belgique Telenet Temps pleinJoin our Finance Team at TelenetAre you ready to take on the role of Team Manager - Tax at our Mechelen headquarters? We are searching for a skilled professional to lead our finance team and oversee all tax matters at the company. Reporting directly to the VP Finance, you will play a crucial role in shaping our tax policies and ensuring compliance.What...
-
Account Manager Health Benelux
il y a 1 semaine
Mechelen, Flandre, Belgique Wolters Kluwer Temps pleinAs the Existing Business Account Manager BeNeLux for Clinical Effectiveness you will be responsible for the retention and Cross and Up-sell in our existing customer base - Hospitals, Universities and Medical Schools, within your assigned territory & reporting to the Country Manager BeNeLux/Nordics.The job can be held either remote / office based in Belgium...
-
Team Manager
il y a 1 semaine
Mechelen, Flandre, Belgique Telenet Temps pleinWorking in the Telenet New Business & Ventures teamDriving innovation and new business forward in a corporate environment. That's the name of the game in this job. That, and a great team of course.In the New Business & Venture Tribe we look for new growth opportunities for Telenet. We work as "pirates in the navy" on building investments in new areas of...
-
Head of Marketing BNL
il y a 1 semaine
Mechelen, Flandre, Belgique CSL Temps pleinTo strengthen our Commercial Affiliate in Mechelen, Belgium , we are currently hiring a Head of Marketing - Benelux (m/f/x) (Fulltime / permanent/ hybrid role - 2 days/week in the office) The Opportunity Reporting directly to the General Manager Benelux and as a key member of the Benelux leadership team, you will drive innovative marketing...
