Responsibilities include;

Manage ‘Client’ or ‘Project’ specific PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting.

Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.

• Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
• Work closely with the clinical operations and project management groups to ensure all PV&DSS activities are performed according to the regulatory and contractual requirements.
• Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.

Education / Qualifications

• Outstanding client interfacing skills, problem solving and project management skills
• Global or international experience in leading safety studies managing budgets and doing the resource planning, writing safety management plans, working in safety data bases and training other people in safety to do the relevant data entry and narrative writing for the cases and using the safety database.
• Problem solving and not getting stressed under pressure- someone who finds a challenge exciting and can understand that business decisions drive our processes not client demanding things their way, which needs negotiation.
• Non-degree + 6-7 yrs safety experience* Associate degree + 5-6 yrs safety experience* Associate degree RN + 5-6 yrs safety experience* BS/BA + 4-5 yrs safety experience* MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience) PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)
• For PharmD, a one year residency of fellowship can be considered relevant experience.
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

Experience

• Compliance with client and global regulatory requirements

• Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines. Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation Good knowledge of ICH guidelines. Good knowledge of medical and drug terminology Work collaboratively with PV&DSS Management’s team Good verbal, written and presentation skills. Good communication. Leadership capabilities Knowledge of Medical Device Reporting desirable Knowledge of aggregate reporting Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.