Pharmacovigilance Specialist

2 weeks ago


Dublin, Ireland TCP Group Full time

TCP Homecare is a healthcare service provider, specializing in direct to patient services which include the dispensing and distribution of pharmaceutical products, home care nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patients home. We are looking for pharmacovigilance specialistwho demonstrates a high degree of self motivation and the ability to adapt to change. This is permanent, full time, Monday to Friday role with attractive hybrid working module available. Key Responsibilities: ? To perform triage of the PV mailbox, manage the mailbox, and maintain strong communication with the client. Ensure all activities are completed within the appropriate timeline. ? Process PV events, and product quality complaints in line the organisations operating procedures. ? Carrying out regular reconciliation of case reports with internal and external sources. ? Manage follow up requests and client queries. This will include liaising directly with nursing teams and the patient care bureau to obtain additional information. ? Perform PV quality checks, and source date verification activities where required. ? Maintain the Pharmacovigilance reporting system as well as provide systematic reporting to inhouse managers and external clients. ? Ensure compliance with TCP SOPs, as well as relevant external procedures and maintain the Pharmacovigilance reporting system. ? Assists in the pulling of operation reports for review of PV reporting standards throughout TCP. ? When required ensure that all team activities are complete within the appropriate timeline and taking the necessary action to maintain compliance. ? Create incidents reports that occur in PV and drive the actions that are required remediate errors. This may require liaising directly with other functional leads to align processes to PV standards. ? Adhere to GVP (good pharmacovigilance practices) guidelines at all times. ? In compliance with client requirements ensure that all service user records and files are managed, maintained and up to date ? Assist PV Manager with compiling data for client service reviews (when required) ? Supporting PV Manager with other activities as assigned ? Supporting PV Manager and representing PV department in audits and inspections (where required) ? Represents yourself in a professional and ethical manner at all times and ensuring customer confidentiality at all times. Role requirements: Degree in life sciences or working towards, highly desirable. High degree of accuracy with attention to detail essential. Familiarity with good pharmacovigilance practices (GVP) desirable. Knowledge of medical and drug terminology would be a distinct advantage. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good knowledge and experience using MS Office would be beneficial. What We Offer in Return: Competitive annual salary 24 days of annual leave, rising with service Pension Scheme Life Assurance Health Insurance Income Protection Education Assistance funding with paid exam and study leave Employee Discount Card You Can Also Expect: A supportive and friendly working environment Regular training courses and opportunities to upskill Promotional opportunities Refer a Friend scheme Social events Cycle to Work scheme Skills: GVP Medical drug terminology. Communication



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