Associate Director Pharmacoepidemiology remote in Bulgaria / Romania
- Employer
- ICON Plc
- Location
- Bulgaria, Homeworking
- Salary
- Competitive
- Start date
- 4 Feb 2023
- Closing date
- 6 Mar 2023
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
What will you be doing?
The Associate Director/Director Pharmacoepidemiology within Pharmacovigilance & Patient Safety will be responsible for:
Furthermore, you may act as a client representative with regulatory agencies, participate in Business Development activities and the RFP process (bid defenses, client consulting, support for full development programs and individual clinical studies). You will guide the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.
What do you need to have?
Skills:
To qualify, applicants must be legally authorized to work in the European Union, and should not require, now or in the future, sponsorship for employment visa status.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-AB1
#LI-Remote
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
What will you be doing?
The Associate Director/Director Pharmacoepidemiology within Pharmacovigilance & Patient Safety will be responsible for:
- Providing strategic input and review of safety documents in the field of pharmaco-epidemiology
- Providing strategic input into post-approval safety commitments / requirements, risk management plans, post-authorization safety studies and risk evaluation and mitigation strategies
- Ensuring oversight of observational studies including claims and EMR studies to describe and quantify safety and benefit-risk ratio, disease epidemiology and real-world usage, disease history, competitive landscape, patient exposure
- Providing guidance and oversight on meta-analysis or systematic literature review in relation to safety and benefit-risk of products
- Providing subject matter expertise, guidance and direction to internal and external stakeholders
- Ensuring optimal management of cross-functional projects, identifies potential risks to project objectives, ensure scientific integrity and cost-effective project delivery
- Developing and maintaining excellent relationships with both internal and external stakeholders
- Maintaining up-to-date knowledge of industry best practices in epidemiology and risk management, recognized as internal expert and go-to person
- Participating in developing new and existing business by attending sales presentations
Furthermore, you may act as a client representative with regulatory agencies, participate in Business Development activities and the RFP process (bid defenses, client consulting, support for full development programs and individual clinical studies). You will guide the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.
What do you need to have?
Skills:
- PhD or Master degree’s in epidemiology with relevant experience as an epidemiologist
- At least 3 -5 years’ experience in a pharmaceutical company or a CRO with excellent knowledge of pharmacoepidemiology, pharmacovigilance, Risk Management, REMS, real-world databases
- Excellent methodological and analytic skills
- Excellent communication and presentation skills
- Good organization and project management skills
- Good interpersonal skills ( i.e. team player)
- Ability to adjust to changing priorities
- Ability to work independently
To qualify, applicants must be legally authorized to work in the European Union, and should not require, now or in the future, sponsorship for employment visa status.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-AB1
#LI-Remote
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