JOB DESCRIPTION. Pharmacovigilance Officer REFERENCE Part Time, Fixed Term

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1 JOB DSCRIPTION POST Pharmacovigilance Officer RFRNC CONTRACT RPORTS TO ROL PURPOS/SUMMARY SCOP Part Time, Fixed Term tctu Manager To provide pharmacovigilance advice and safety reporting services to support regulatory compliance within the research studies carried out at LSTM To assist in ensuring that safety reporting complies with UK and international regulatory guidelines and to input into protocol development specifically around drug and device safety reporting. To support the optimisation of the pharmacovigilance process for LSTM and to input into documentation for safety reporting where applicable across LSTM research. To provide training to various groups across LSTM including research teams and students. ROL SPCIFIC RSPONSIBILITIS KY RSPONSIBILITIS 1 Main PV responsibilities KY ACTIONS Review of protocols for pharmacovigilance; guidance and advice on required and desirable pharmacovigilance activities for compliance with appropriate regulatory, institutional and local guidelines and regulations Support the setup and implementation of pharmacovigilance activities for research studies at both local and central level, including staff training, drafting and reviewing SOPs, ongoing review of SOPs, facilitating drug supply Assisting in research activities, including liaising with appropriate partners (such as ethics committees, DSMBs, manufacturers, trial steering committees etc) nsure timely notification of safety-related issues, in line with institutional and relevant legislative statutes and regulations Data entry into data capture software and databases Support the ongoing monitoring of study conduct to ensure compliance with study safety SOPs via site visits and study metrics Assisting in the reconciliation of study databases Assisting with analysing data and the preparation of clinical study reports, publications, final reports and presentations

2 2 Main Reporting Responsibilities Supervision of the receipt, processing and forwarding of case reports from on-going research projects; ongoing management of the pharmacovigilance system Undertake event processing and assist with case review for errors, completeness and quality; liaising with study teams to resolve discrepancies and encourage compliance with reporting timelines Assist with case review for clinical significance and identification of reports (SAs and SUSARs) to be distributed to partners and relevant regulatory authorities, as per SOPs and within specified timelines Continuous review of aggregated safety data as per SOPs, to ensure potential safety issues are identified in a timely manner Periodic review of the database for potential safety issues Assist with quality assurance of case processing activities Preparation of regular DSMB and Interim safety reports Delivery of study-specific and recipient-specific reports to allow monitoring of study performance and compliance with SOPs, and allow continuous monitoring for potential safety issues Ad hoc database review and reporting in response to potential safety signals and requests from partners 3 Main Training Responsibilities Support the pharmacovigilance component of GCP training conducted at LSTM Where required, support the generic pharmacovigilance component of GCP training at site-level Assist with integrating safety management training into the research integrity sessions for PGR s etc Support the development of tools to help enhance understanding of pharmacovigilance at all levels across the organisation Provide specific training for Research Governance and thics staff within LSTM and for partner organisations Advise and train on supply chain management and GDP as and where necessary FURTHR RSPONSIBILITIS KY RSPONSIBILITIS 1 General KY ACTIONS Any other duties commensurate with the grade and nature of the role Promote equality of opportunity and inclusive practice in all aspects of work undertaken Any other duties commensurate with the grade and nature of the role

3 KY RSPONSIBILITIS KY ACTIONS

4 PRSON SPCIFICATION POST Pharmacovigilance Officer COMPTNCY CRITRIA Qualifications, Training & Knowledge Degree in Pharmacy or other relevant life sciences or public health related discipline SSNTIAL/ DSIRABL ASSSSMNT Application Training in pharmacovigilance Application Understanding of guidelines/legislation for pharmacovigilance Understanding of relevant medical terminology Understanding and working knowledge of Good Clinical Practice Understanding of database management tools xperience xperience in pharmacovigilance vent processing experience Clinical or research experience Proven ability working collaboratively across partners in longterm project(s) xperience of working under pressure and proven ability of working to tight targets and deadlines Familiarity with clinical trials and other studies involving investigational medicinal products D xperience of applying pharmacovigilance methodology xperience of data entry/inputting. xperience of trial sponsorship duties D Clinical or research experience in developing countries D xperience of MedDRA and other standardised dictionaries D Knowledge and use of statistical packages D xperience of data capture databases such as RDcap or Datafax D Familiar with developing countries working environment D Skills & Behaviours Attention to detail Sound working knowledge and skills relating to Microsoft Office Applications Project administration skills

5 COMPTNCY CRITRIA Good oral and written communication skills; fluency in spoken and written nglish xcellent organisational abilities and time management skills with the ability to effectively prioritise workload Ability to work on own initiative and multi-task to meet competing deadlines Ability to work co-operatively and productively as a team member as well as independently SSNTIAL/ DSIRABL ASSSSMNT Strong interpersonal and relationship building skills Proficiency in safety systems D Circumstances Willingness to travel