Drug Safety Manager

Job Description

Key Deliverables of this position: -
  • Collection and timely reporting of all adverse events/safety reports to GSRS or external provider asdefined both by internal SOPs and UK and Irish regulations
  • Assisting in Audit & Inspection readiness as required and assisting with audits/monitoring vi sits ofexternal third-party vendors

Accountability:

1. Management and oversight of third parties

• Maintaining oversight of outsourced vendors with PV responsibilities

• Review of external provider reports for AEs and PCs

• Assisting with PV Operations Vendor’s compliance and follow-up activities

• Responsible for PV oversight for Company’s patient support programs and homecare delivery providers

2. Responsible for the overall provision of safety report handling relating to BI UKI. Maintenance of local PV

processes and procedures

3. Training and tracking of all BI UKI and external providers on appropriate PV-related procedures

4. Reviewing local and national legislation (MHRA or HPRA) to maintain an awareness of local regulations and ensuring

local processes are aligned with these requirements

5. Notifying Global Safety & Regulatory Sciences (GSRS) of any contractual arrangements with external

providers with significance for handling AE information

6. Ensuring awareness of any programs/contractual arrangements with external providers with significance for

handling AE information according to relevant procedures

7. Assisting GSRS with regulatory requests or audits/inspections

8. Reviewing various documents in InSCite from pharmacovigilance perspective

9. Reviewing and tracking local literature for safety-related content

10. Tracking safety data exchange agreements

11. Performing local reconciliations with third party vendors

12. Assisting GSRS with late case investigations. Overseeing PV-related CAPA/Exception

13. Assisting with monthly reports on PV metrics

Qualifications

  • Bachelors Degree in life sciences degree
  • Minimum of 5 years of industry
  • PV industry experience
  • Knowledge of local regulations
  • High attention to detail
  • Ability to work independently on routine and new assignments
  • Good experience of working in an affiliate environment
  • Experience of working with homecare companies and patient support programs
  • Process driven with ability to set work systems, procedures, and track performance
  • Understanding of commercial business needs and strategy
  • Significant experience of ICSR processing and quality checking




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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