Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds… ClinChoice is searching for a Safety Specialist to work with one of our pharmaceutical partners. This can be a home-based, permanent position. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Main Job 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 Clinical Operations CROs, providing Company's assessment in terms of reportability/queries. Management of pregnancy cases. Management of follow- up requests to the Clinical Operations 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/nonconformities management. Education, Experience and Skills: Master's degree in science, medicine, biology, pharmacy or related fields. Additional background in Pharmacovigilance will be considered as a plus. Able to communicate clearly and accurately in both written and spoken English and Italian. 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. 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. 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. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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 is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Safety Specialist, Pharmacovigilance, SAE, SUSAR, Clinical Trials, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated #LI-CM1 #LI-FULLTIME #PERMANENT