Pharmacovigilance Assistant
Reporting Lines
Report to the Pharmacovigilance Officer.
Main Function/Responsibilities of the Job
§ Reporting of ADRs to regulatory authorities.
§ Receive and process ADRs received from the MHRA.
§ Follow up with physicians and other healthcare professionals regarding ADRs.
§ Receiving and processing literature searches.
§ Liaise with external pharmacovigilance providers and translation companies when these services are required.
§ To update the ADR tracker with new information.
§ To update the safety database with new information.
§ To prepare PSUR?s 3-yearly to maintain licences
§ To prepare variation applications for changes to safety or clinical information.
§ To be available to answer medical information/technical queries.
§ Maintain knowledge of current pharmacovigilance legislation, guidelines and internal standard operating procedures (SOPs).
Ancillary Tasks
§ To be responsible for the cleanliness and tidiness of your individual work station, to ensure a standard of good housekeeping in all areas of the Company.
In addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your Supervisor and Manager from time to time.
To enquire about our current vacancies, or for more information, at working at Rosemont, please send an e-mail to recruitment@rosemontpharma.com |