Description:
Location: Italy

Schedule: Home-based, full-time

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible resourcing solutions, is currently searching for a Safety Specialist in Italy to be dedicated to one of our partner companies - an international pharmaceutical company, with focus on Respiratory, Rare Disease and Paediatrics Therapeutic Areas.

This is primarily a home-based role in the Milan, Bologna or Parma area with the expectations to come to the Sponsor's office one or two days per week.

As this is a client-facing role, we are looking for confident candidates with strong management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Job specific tasks and responsibilities:

• Support to Company Staff for the following activities, pursuant to the terms of the applicable legislation and Company's procedures
• Check of SAE/eSAE received in Company's sponsored Clinical trials, interacting with Clin Ops CROs, providing Company's assessment in terms of reportability/queries
• Management of pregnancy cases
• Management of follow- up requests to the ClinOps CROs
• Overall SAEs monitoring and tracking
• Interaction with the Company Global Pharmacovigilance Service Provider (PVSP) and other Company's personnel
• Support in the preparation of documentation for SUSAR/other safety reporting submissions
• Support in SAE reconciliation activities
• Other activities connected with PV management in clinical trials
• Management of other study-specific activities, pursuant to the terms of the applicable legislation and Company's procedures: revision of study specific documents, check of costs, US specific activities such as transfer of regulatory obligations, complaint management, responses to authorities, informed consent, study team meetings, kick off meetings, lessons learned, bid defense meetings, RFP preparation, CRF revision, Investigators meeting, Unblinding tool management, data review (including coding, attendance to DRM, revision of queries, ongoing review of Data Quality Reports or other sources for ongoing check), CSR revision (including narratives), Safety committees management (including charter preparation, SAC/ISMB attendance, preparation of documentation. Including MACE activities), TMF management, study specific deviations/non conformities management

Education and Experience:

• Bachelor's degree
• Experience in clinical research or healthcare related industry, including as a Safety Specialist
• Working knowledge of international regulatory and ICH-GCP guidelines
• Experience managing PV is essential

Skills:

• Good documentation practices
• Self-motivated and displays initiative
• Experience of working as part of a large team with proven ability to make an active contribution to the team's performance and team working
• Able to communicate clearly and accurately in both written and spoken English and Italian
• Effectively collaborates with team members
• Proven organisational skills demonstrated by the ability to understand and prioritise instructions and deliver against commitments on time
• Proficient skills across multiple computer applications including Microsoft Office, Impact, etc
• Attention to detail

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @https://www.talentsourcelifesciences.com/jobs or please contact careers@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Safety, Pharmacovigilance, SUSAR, Clinical Trials, TMF, Drug Safety
Skills: clinical trials, Drug Safety, Pharmacovigilance, SUSAR, TMF Location: Italy Share:

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