£45k per year + Benefits
020 7378 5476
My Client is looking to recruit a Global Adverse Event & Compliance Manager for their Research Franchise this will include the primary market research consultancies of the other arms of their Research Group. For over 30 years, my client has provided strategic consulting services for global pharmaceutical clients and successfully supported the development, launch and marketing of many pharmaceutical brands.
As the Quality System & Compliance Specialist, you provide support to the Research Franchise, including: maintenance and adherence to policies and SOPs; ensure business units are compliant with all relevant country-specific legislation, including GDPR, all professional codes of conduct/practice, rules and regulations of regulatory agencies and client-specific policies and procedures; and provide project compliance support. The ideal candidates will possess the following:
Responsible for the maintenance of the quality manual and standard operating procedures required for ISO 20252 certification, as well as client-driven audits.
Translate companies high level policies into detailed best practice within the Research Franchise, for approval by Senior Staff.
Provide support for regular audits against internal standard operating procedures (SOP) and industry standards to meet regulatory and client-specific requirements, including maintaining documentation and records.
Client Risk Assessments
Coordinate with relevant departments to ensure efficient completion of Client Risk Assessments, including completing any company-specific information associated with day-to-day practice in market research.
Security Evaluation Coordination
Ensure third party security evaluations are completed for all subscription services and tools used to support the market research process, by coordinating with the relevant parties.
Ethical and Legal
Provide support on ethical and legal responsibilities when conducting market research.
Help implement processes and procedures to meet legal, regulatory and client-specific requirements
Review compliance-related aspects of agreements with clients, regulatory guidelines and updates and interpret and communicate information
Must be conversant with global data privacy requirements (GDPR specifically) and specific client privacy requirements, ensuring all client requirements are adhered to and communicated throughout the company.
Provide Adverse Event Reporting project and client-level support
Ensure AEs are correctly identified and reported in accordance with client specifications and market research codes of conduct
Ensure staff and subcontractors are trained to correctly identify AEs according to standards and client-specific procedures
Liaise with clients’ drug safety departments
Ensure that records are maintained for possible audits (i.e., training logs, AE reports, reconciliations, etc.)
Assist with the completion and timely filing of reports required by pharmaceutical companies
Ensure compliance with all specific client AE documentation and regulations
Key skills & Competencies Required:
Bachelor’s Degree plus 3-5 years of quality system/compliance/operations experience
MUST HAVE A MARKET RESEARCH BACKGROUND
Ability to proactively identify and anticipate risk to the business in a complex environment
Good analytical/judgment capabilities
Strong organizational, communication and audit skills
Ability to manage both time and priority constraints, and to manage multiple priorities simultaneously
Ability to lead internal training and meetings
Proficiency in Word, Excel, PowerPoint and Outlook
Strong project management skills
Excellent oral and written communication skills
Strong people skills – able to use appropriate persuasion to ensure that processes are followed
To discuss this interesting and unusual role in full then please contact mark on 0207 378 5476 or mark.leigh@suehill .com