£40k - 45k per year
almost 3 years ago
My client a research franchise is recruiting for a Global Adverse Event and Compliance Manager, providing strategic consultant services for global pharmaceutical clients and successfully supported the development, launch and marketing of many pharmaceutical brands.
The purpose of the role is maintenance and adherence to policies and SOPs; ensure business units are complaint 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.
Key Activities Will Include:
- Work with the Global AE and Compliance Manager and other key members in the team to ensure that appropriate standards, systems and procedures are developed and identified, documented and followed to maximise the quality of work performed in the team.
- Work with relevant individuals, third parties and client staff where appropriate, on issues related to standards, systems, procedures and working practices.
- Work with Global AE and Compliance Manager to create descriptions and summaries in Word, PowerPoint to document and communicate standards, systems, procedures and working practices to the team and clients if appropriate.
- Work with the Global AE and Compliance Manager and Group compliance team to prepare for internal and client audits.
- Work with the Global AE and Compliance Manager and other key members of the team to investigate irregularities and non-compliance issues.
- Work with senior team members in preparing responses to Requests for Information received from clients relating to the groups Standard Office Procedures (SOPs), business systems and methods of working.
- Work with Global AE and Compliance Manager in ensuring compliance of the group in relation to General Data Protection Regulation (GDPR) and other relevant legislation in all activities.
- Work with the Global AE and Compliance Manager in working with the group compliance and IT teams to ensure relevant processes and procedures are implemented and followed.
- Work with Global AE and Compliance Manager in the development and maintenance of new and existing Standard Office Procedures (SOPs).
- Work with Global AE and Compliance Manager and Operations in performing due diligence assessments on key existing and future suppliers and vendors.
- Work with Global AE and Compliance Manager in reviewing supplier contracts to ensure appropriate contract language is included
Responsible for the maintenance of the quality manual and standard operating procedures required for ISO 20252 certification, as well as client-driven audits.
Translate Group 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.
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
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.
Bachelor’s Degree plus 3-5 years of quality system/compliance/operations experience