TCP Group is an innovative health services provider specialising in 'direct to' patient and pharmaceutical services on a national scale.
We are looking for a Pharmacovigilance officer who demonstrates a high degree of self-motivation and the ability to adapt to change.
- Degree in life sciences ideal.
- Drug Safety experience including actual experience processing AE/SAE reports, generating narratives, queries.
- Previous experience with record management, documentation control, and SOP review.
- Experience working in a regulated environment.
- High degree of accuracy with attention to detail.
- 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.
- Be involved in processing PV events, and product quality complaints in line the organisations operating procedures.
- Be involved in 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.
- Be involved PV quality checks, and source date verification activities where required.
- Act as a key information resource to pharmacovigilance team for training and other multidisciplinary teams.
- Maintain the Pharmacovigilance reporting system as well as provide systematic reporting to in-house managers and external clients.
- Ensure that the PV team are compliant with TCP SOPs, and maintain the Pharmacovigilance reporting system. This will also include assisting in the development of procedures.
- Represents yourself in a professional and ethical manner at all times and ensuring customer confidentiality at all times.
- Familiarity of good pharmacovigilance practices (GVP).
- Knowledge of medical and drug terminology desirable.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good IT skills, preferably with knowledge of MS office and Windows would be beneficial.