Safety Surveillance and Aggregate Report Oversight Associate
A large biotechnology company has an opening for a Safety Surveillance and Aggregate Associate (SSA) in their Luton based office. The organisation has a strong reputation for developing innovative therapies, offering the chance to bring effective and innovative change to medicine.
- Support with developing sourcing strategies for RFP and bring into scope the business requirements for the new vendor.
- Support with the development of the scopes of work on behalf of the business and facilitate contract execution by collaborating with relevant stakeholders.
- Contribute to and oversee the onboarding activities for the new vendor (IT, training, communication, SharePoint).
- Support with maintaining the procedures in place for the established vendors.
- Creation of new procedures and tools to improve the quality, accuracy, and efficiency of the current SSA processes.
- Development of training and processes to ensure streamlined communication between vendor and relevant stakeholders.
- Involved in vendor workload forecasting and budget maintenance.
- Performs general administrative tasks related to vendor management activities such as maintaining spreadsheets and maintaining the applicable vendor management SharePoint.
- Provide any required support during inspections and (vendor)audits.
- Involved in the exploration of new IT solutions which can support vendor oversight and increase efficiency within the SSA group.
- Build and maintain close relationships with the vendor and with multi-functional teams based in different regions within and outside Global Safety and Regulatory Sciences.
Skills and Requirements
- Education Bachelor's Degree in biologic or natural science; or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
- Minimum 3 years pharmaceutical or biotech industry experience
- Familiar with Pharmacovigilance and drug development, including knowledge of clinical trial safety regulations and post-marketing safety regulations, case processing and safety database concepts.
- Basic knowledge or experience with aspects of outsourcing and/or vendor oversight.
- Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format.
- Comfortable with medical terminology and American Medical Association manual of style.
- Strong skills in performing editorial, technical, and scientific authoring.
- Strong communication and organizational skills, including the ability to prioritize independently.
- Basic knowledge of common data processing software (SharePoint, EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at 0207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.