Senior Drug Safety Associate
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An exciting opportunity has arisen in London for a Senior Drug Safety Associate to join a leading pharmaceutical organisation where you will oversee the operational elements of pharmacovigilance activities that are outsourced to a PV service provider and in ensuring the appropriate handling of safety information within the organisation.
- Accountable for all operational, quality and administrative aspects of Drug Safety at the organisation in connection with the collection, safety evaluation, reporting, cross reporting, dissemination and filing of all adverse event reports, ensuring that internal and regulatory timelines are met.
- Reviewing PVSP SOPs when required during study set up.
- Review and provide input into the SAE Processing Guideline/Safety Management Plan for clinical studies.
- Responsible for overseeing all aspects of PV outsource to PV Service Providers, ensuring they are adhering to company SAE Processing Guideline/Safety Management Plan and local regulations and that cases are being processed in a timely fashion.
Supporting Project Teams:
- Provide support and subject matter advice, liaising with Clinical Scientists and other study team members on issues relating to drug safety.
- Review and provide input into key study documents during clinical trial set up stage. These may include Protocol, SAE Reconciliation Plan, Data Management Plan, Informed Consent Form, Clinical Science Review Plan etc.
- Assist the team in the coding of AEs and medications using appropriate versions of the available dictionaries (MedDRA and WHO Drug).
- Attend and actively participate in relevant internal/external meetings which involve safety matters including SP bid defence meetings. Contribute to request-for-proposal documentation regarding drug safety activities.
- Communicate effectively and maintain professional working relationships with PVSP drug safety departments, PVJ, medical officers and medical monitors.
Periodic Safety Reports:
- Assist the HPV to prepare periodic safety reports (and ensure accuracy of review and reporting. When required, attend DSUR meetings, taking the lead in coordination of all DSUR activities and providing associated timelines etc.
- Review Annual Progress Reports submitted to Research Ethics Committees, ensuring study progress is communicated in a timely manner.
- All activities to be carried out in accordance with appropriate ICH GCP and Good PV practice.
- Conduct oneself at all times in accordance with the organisations Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensure training in these areas is kept up-to-date at all times.
- Review/audit CRO SAE reporting/pharmacovigilance procedures as and when appropriate.
- Assist the HPV to review, update and develop drug safety SOPs and working guidelines, where appropriate lead the review and authorship.
Any other assigned duties.
- Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work
- Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
- Must be diplomatic and tactful in liaising with staff and management and be culturally aware.
- Robust written and spoken English.
- Proven ability for working independently with minimal supervision.
- Must be meticulous and methodical, with the ability to review both data and procedures in detail.
- Ideally a BSc (or equivalent) in life sciences or a combination of education and demonstrable drug safety experience gained within a contract research organisation, pharmaceutical, or biotechnology company.
- A strong and detailed understanding of pharmacovigilance processes and have worked without supervision in a drug safety department.
- Can demonstrate their experience in all aspects pharmacovigilance practice, especially case processing and reporting.
- Solid demonstrable knowledge and practical experience of GCP and Good PV practice.
- Relevant recent experience in PV practice, MedDRA coding and WHO Drug dictionary training to maintain their knowledge and skills.
- Experience working in a team environment under time constraints and resource pressures.
- Experience of conducting and participating in presentations and workshops.
- Excellent computer skills in MS Office, ideally with some experience of intranet maintenance (content) for Drug Safety.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£350 - £400 per day
Hobson Prior are working with a global pharmaceutical company who are currently looking for a Pharmacovigilance Processes Manager to join them on a contract basis in Macclesfield remotely.