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Assoc Director, Signal Management and Innovation - #26-24152

US Tech Solutions

Role overview

Qualifications

  • Health care background or life science degree/Bachelors required; degree in life sciences preferred
  • Excellent document creation skills
  • In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis
  • Critical, strategic thinking and decision-making skills

Responsibilities

  • Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes
  • Represents Pharmacovigilance externally at a global level as an authoritative expert on signal detection processes
  • Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance
  • Conducts project activities for designated processes

Key facts

Hard skills

Other skills

  • Training And Development
  • Communication
  • Presentations
  • Critical Thinking
  • Decision Making
  • Computer Literacy

About the company

US Tech Solutions logo

US Tech Solutions

Staffing & Recruiting

USTECH SOLUTIONS is the largest privately owned diversity workforce partner with a global footprint. For 20+ years, we have partnered with leading MSPs and some of the world’s largest enterprises to deliver a flexible workforce. We serve Fortune 500 giants and growing businesses alike, reinventing the role of humans in a digital workforce. ‘Reinventing Human’ is about connecting you with top talent and seamlessly integrating new hires into your programs through our next gen AI powered Talent platforms. As the largest private diversity supplier in the US, we champion inclusion and unlock hidden potential. We work with leading MSPs and are a trusted strategic partner to the world’s top brands. At USTECH SOLUTIONS, we're inverting the talent hiring pyramid by offering a range of solutions from curated talent pools, workforce management services, and IT services resourcing to IC compliance. Our legacy and close affinity to the computing industry has equipped us with the expertise and vision to provision AI platform solutions that help organizations to innovate faster. Considering Statement of Work? Meet US Tech Digital (ustechdigital.com). We're helping businesses achieve digital leadership through our tailored SOW solutions, utilizing market-leading technology products and our proprietary in-house developed platform solutions. Explore our full range of services and solutions by visiting our website: ustechsolutions.com

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size1001 - 5000

Links

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Job description

Duration: 6 months

Objective / Purpose:
  • Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences).
  • Ensures that Signal Management processes and activities are compliant with Global Health Authority expectations, including EU regulations and EU regulatory authority and inspectors’ expectations.
  • Represents Pharmacovigilance and  externally at a global level as an authoritative expert on signal detection processes.
  • Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.
  • Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
  • Leads interactions and oversight of signal management activities conducted by any vendor.
Accountabilities:
  • Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
  • Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.
  • Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
  • Designs and delivers relevant training as appropriate.
  • Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate.
  • Conduct project activities for designated processes.
  • Any other tasks assigned by manager to assist in related departmental activities.
Education & Competencies (Technical and Behavioral):
  • Health care background or life science degree/Bachelors required; degree in life sciences preferred
  • Excellent document creation skills
  • In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis
  • Critical, strategic thinking and decision-making skills
  • Ability to review, analyze, interpret and present complex data to a high standard
  • Global player in a PV organization with the ability to adapt to change
  • Excellent communication and presentation skills
  • Good level of computer literacy
  • Excellent organization skills and ability to prioritize
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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