Drug Safety Manager
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
If you are a strong people and project leader who has experience with drug safety / pharmacovigilance, we want to hear from you. Our Drug Safety Manager will lead a team of people onsite at our Mexico City office as well as be responsible for study management. As a line manager you would work to develop employees, manage interpersonal issues, oversee workload, conduct performance reviews, set training agendas, and ensure that activity targets are met. As a project manager you should be deft with invoicing, out of scope work, change orders, the ability to manage several drug safety projects at once, and ensure that the overall client relationship runs smoothly. To qualify you must have relevant industry experience, be legally authorized to work in Mexico without restrictions, as well as speaking and writing fluently in English. This is an office based role reporting to our Mexico City office.
Overview of the Role
This role ensures that projects within
Medical and Safety run efficiently, accurately and in accordance with ICON
standards, regulatory requirements, and contractual obligations to sponsors,
ensures the daily project operations of assigned safety projects, provides
project management on Drug Safety projects, and oversees Drug Safety and
Administrative staff.
Responsibilities of the Role
·
As a
Manager, the employee is expected to recognize the importance of
and create a culture of process improvement with a focus on
streamlining our processes adding value to our business and meeting client
needs.
·
Travel
(up to approximately 15%) domestic and/or international as applicable
·
Ensure
all project safety activities are completed in accordance with ICON SOPs, Study
Specific Procedures, regulatory requirements, and Sponsors processes
·
Keep
management appraised of any potential/actual study or staffing issues and
develop solutions for same
·
Develop
and implement department training
·
Assist
in training of other departments, as requested
·
Maintain
quality review metrics and attend project quality meetings, as required
·
Assist
with maintenance of project budgets and oversight by identifying out of scope
activities
·
Assist
upper management with resourcing and business development activities
·
Attend
bid defence meetings, as requested
·
Manage
small to mid-size drug safety projects, including Sponsor liaison, and management
of timelines and budgets, as appropriate
·
Ensure
audit readiness and/or MSS representation at audits
·
Develop
safety plans, study specific procedures, and workflows for clients, as
requested
·
Actively
identify options for process improvement
·
Supervise
maintenance of project drug safety files as regionally applicable
·
Coordinate
any committee activities as applicable under supervision
·
Perform
other activities as identified and requested by managementManage MSS projects in accordance with established timelines,
budget, quality standards and/or contractual requirements
·
Develop supporting staff skills, encourage growth and provide
regular performance feedback
·
Provide project and/or line management of assigned Drug Safety and
Administrative staff
·
Serve as a mentor and role model for Drug Safety staff.
Role Requirements
·
A minimum of 4 years
of relevant clinical research / pharmaceutical industry experience, preferably
with at least 2 years’ experience in pharmacovigilance / drug safety.
·
Medical/science background (nursing preferred) and/or bachelor’s
degree or local equivalent
·
Ability to interact effectively and professionally with various
levels of staff for both internal and external departments, vendors, or
Sponsors
·
Demonstration of professional demeanor, judgment and discernment
in interactions with clients, colleagues, and other staff
·
Thorough knowledge of global safety processes and regulations
·
Good knowledge of medical terminology and coding systems
·
Very good computer skills
·
Excellent organizational skills
·
Excellent communication skills
·
Very good presentation skills
·
Very good ability to mentor staff
·
Ability to work independently or lead study teams
·
Ability to self-start and show initiative
·
Detail oriented
·
Fluent in written and verbal English
Increasing competition and regulatory demands
are putting more and more pressure on pharmaceutical companies and medical
device manufacturers to reduce the product development timelines. You can be part of the solution to drive
efficiency and improve results for our partners and ultimately for the
population the investigational product may eventually serve. We are a company of 13,500
employees in forty countries globally. We differentiate ourselves by
developing innovative solutions to bring life-saving drugs to market faster and
in a more cost-effective way to foster better patient outcomes. We are a top five clinical research
organization with solid earnings and growth potential. Our belief in excellence is our core value in
all that we do for our sponsor partners and the patients that we serve.
As a company we strive to exceed our customers’ expectations in drug
development solutions.
Other than
working with a great team of smart and energetic people, we also offer a very
competitive salary and benefits package that includes an excellent retirement
plan, health coverage, paid time off, income protection insurance programs, and
staff recognition schemes. We care about our people, since they are the
key to our success. We provide an open and friendly work environment where we
empower people and provide them with opportunities to develop their long term
career. Caring for patients
while enjoying what we do and delivering great results is something we can
achieve if we know we can count on each other and have a clear vision of where
we want to go.
ICON
is an equal opportunity employer – Minorities/Females/Disabled/Veterans and
committed to providing a workplace free of any discrimination or harassment.
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
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