Senior Manager, Pharmacovigilance
- Brazil
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As the Senior Manager – Pharmacovigilance, you will be responsible for overseeing a large team of PV professionals, for an assigned FSP client program. Reporting into the Director of Clinical Operations, this is a critical role in supporting the further development of the fully embedded team. There will also be further scope to support and lead other teams within the business. You will also have the opportunity to play a key role in department initiatives and to advance your management skills as part of the Pharmacovigilance FSP leadership team
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
What you will be doing:
- Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (E.g. may provide services for Serious Adverse Events (SAE)/Adverse Reactions /Medical Device Report management, periodic safety reports, adjudication, coding, product complaints).
- Monitors projects to assure company profitability and associated project goals and objectives are being met
- Develops, implements, and monitors profitability, objectives and metrics of assigned group of direct reports.
- Supports departmental initiatives and development of SOPs, investigation of process related issues, consulting on safety processes, tools, and regulatory compliance.
- May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone safety and medical information projects, and the main pharmacovigilance point of contact for assigned projects
- Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase
- Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company
- Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager group-related project tasks; provides leadership in the delivery of related services to clients.
- Supports direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required
- Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
You are:
- Bachelor’s degree (or higher) in a healthcare-related or life science field
- Solid experience at a senior level within Pharmacovigilance within a CRO or BPO
- Broad knowledge of clinical development and / or safety requirements from pre-clinical to post marketing.
- Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team
- Excellent Project Management skills
- Analytical mindset
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, 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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
![A picture of Debora Oh](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/Oi_Ywfaw1E2c5AjadgdpUA/75/debora-oh-thumbnail.jpg)
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
![A picture of Yemi Moses](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/voIjKGzvOUdxWAjadgXIBA/75/yemi-moses-thumbnail.jpg)
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
![A picture of Suzaita](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/x7o-Djy2R0cv_gjbLGx6Ig/75/Suzaita.png)
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Who we are
Press play to find out more
![](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/Blob/img/full-width-video.jpg?v=2023.15273-main)
Similar jobs at ICON
Salary
Location
France
Department
Clinical Monitoring
Location
France
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2023-106829
Expiry date
01/01/0001
Author
Dominique CarilienAuthor
Dominique CarilienSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-111436
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-111435
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-111434
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Montreal
Department
Clinical Monitoring
Location
Montreal
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-111431
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie Pruitt