Responsible for completing day to day operational activities in relation to the set up and maintenance of Distribution Anchors (DAs) in the Global Safety System. The DCM Analyst will also participate in collaborations with internal and external business partners to support the maintenance of the DAs to meet Regulatory reporting requirements. The Analyst will help to write and update procedural documents be involved in continuous process improvement metrics collection and training / mentoring of other staff in DCM. The position will also complete other relevant tasks of special assignments and provide back up to the Manager as required.

• Performs Distribution Anchor (DA) related activities.

• Leads interactions with Local Safety Officers to gather regulatory intelligence to support Distribution rule implementation and maintenance.

• Documents local country regulatory requirements and interprets requirements into Distribution Anchors technical requirements.

• Creates Distribution Anchors directly into the Global Safety system.

• Manages daily workload and ensures Distribution rule related tasks are completed timely as allocated to ensure completion of daily activities.

• Performs Quality Control activities of individual and team related work.

• Performs informal Testing of new/modified Distribution Anchors as required.

• Close liaison with Distribution Configuration Management team regarding workload management. Deputizes for Manager/Director as identified.

• Contributes in team meetings and performs daily liaison with team members to identify and resolve processing issues

• Drives the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.

• Develops Metrics to monitor key performance indicators across key Distribution Configuration Management areas.

• Assists Manager with implementation of processes and issue management.

Operational Activities

• Identifies and resolves issues or prepares documentation and options for solution where escalation is required.

• Is responsible for impact assessments and bolus management activities relating to Das.

Liaison with stakeholders and 3rd parties

• Provide support to clarify procedures (e.g. training) to ensure compliance relating to collaboration with business partners European Medicines Agency (EMA) Food and Drug Administration (FDA) and other Global Regulatory Authorities (RAs) Local Safety Officers (LSOs) Pharmacovigilance (PV) nominated persons and other groups such as Global Clinical Operations (GCO) licensing partners and Regulatory Affairs (RA)

• Assist with Service Level Agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs) and/or Pharmacovigilance Agreements (PVAs). In particular the oversight of the DAs within the Global Safety system

• Liaise with other functional areas to facilitate resolution of queries and issues.

Projects and Initiatives

• Acts as Subject Matter Expert (SME) when requested in one or more of the below activities:

  • Regulatory Reporting intelligence

  • Quality monitoring activities

  • Process/system improvement

  • Compliance and quality metrics preparation

  • Controlled document creation/update

  • Quality Investigations and CAPA activities

• Identifies and develops solutions for areas needing improvement and considers the use of technology for the automation of process steps.

Quality and Compliance

• Develops / updates Standard Operating Procedures (SOPs) and other controlled documents relevant for the coordination of tasks business continuity and audit/inspection readiness.

• Represents Distribution Configuration Management in audits and inspections when requested and provides support for document requests.

• Investigate document and track compliance related data and identify any trends.

Other

• Maintain knowledge on worldwide regulations/guidance related to Individual Case Safety Report (ICSR) case processing and reporting activities.

Minimum Qualification

Education:

• Degree and/or relevant work experience advanced degree is preferred

Required Experience

• Developed Understanding of US and EU electronic regulatory reporting requirements for ICSRs.

• Accumulated expertise in pharmacovigilance operations related activities including single case processing database queries expedited reporting.

• Knowledge of regional and global safety regulations

• Good understanding of technologies systems and databases related to E2B electronic reporting.

• Highly reliable and compliant with legal and company guidelines

• Excellent organizational and communication skills including presentation abilities.

• Ability to produce high quality work under time critical and high-pressure situations.

• Project Management Skills desirable