Clinical Safety Analyst III LATAM- Location: Brazil Hybrid (3x at Vila Olimpia´s office)
Who We Are
Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.
Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.
Basic Functions and Responsibilities includes, but are not limited to:
▪ Be deputy in the absence of QPPV (Qualified Person for Pharmacovigilance);
▪ Perform overview of the safety profiles and any emerging safety concerns for the project study drugs;
▪ Follow all local and global requirements regarding pharmacovigilance regulated by the MoH (Ministry of Health); ▪ Regarding AE (Adverse Events): AE Coding using MedDRA dictionary, assess/review seriousness, severity, causality and predictability of suspected adverse reactions received;
▪ Forward and oversees notifications to the MoH as established all local regulations according local requirements; ▪ Handling the follow-up of severe cases without clinical outcome. In this case, this new information must also be forwarded to the MoH;
▪ Update the routine recording activities and information related to notifications of adverse events received;
▪ File notifications systematically, in order to enable their traceability and quick access to information;
▪ Develop, review, and maintain procedures (SOPs, Manual, Work Instructions, Plans) that enables the identification of safety signs related to its products;
▪ Implement/Develop/Review safety management plan and risk minimization plan when requested; ▪ Answer questions from health authorities for assessing the safety and efficacy product profile;
▪ To ensure the compliance of ICH-GCP requirements regarding PV;
▪ Assisting with the development of Intrials policies, processes, and procedures;
▪ Conducting or assisting with pharmacovigilance training sessions;
▪ Develop and review safety reports as such as: DSUR, Periodic Line-listings, DSMB reports and Clinical Safety Report (Safety part);
▪ Responsible for process ICSRs end-to-end and perform FUP when needed.
▪ To manage/handle Post trials Access studies: Lead Project, communications with sites and sponsor, logistics staff support.
Primary Activities includes, but are not limited to:
Develops and update Intrials safety documents;
▪ Ensures compliance with Local and international regulations when writing and reviewing protocols, safety management plan, DSMB reports, and submission;
▪ Develops training materials and conduct trainings for study implementation based on company policies and standard operating procedures (SOPs);
▪ Provides input with questionnaire development, analysis, study design, and material management;
▪ Plan, organize, and manage resources/processes for successful completion of study goals;
▪ Assists with safety information the scientific development, considering writing the Protocol;
▪ Creates or adapts Intrials safety documents, considering the procedures based on overall or Sponsor’s procedures and prevailing regulations;
▪ Provides training of relevant or new SOPs to concerned employees based on the training plan.
Requirements:
▪ Degree in health science area (Pharmacy, Biology, Bio-Medicine, etc.);
▪ Good knowledge of concepts, practices, and procedures for safety in clinical trials studies under ICH-GCP and GVP guidelines and local and global regulations;
▪ Excellent oral and written communication, interpersonal and public speaking skills;
▪ Strong attention to detail, project management and organizational skills;
▪ Ability to make sound judgments and properly assess situations;
▪ Works on problems of moderate scope that require analysis or interpretation of identifiable factors;
▪ Excellent decision-making and problem-solving skills;
▪ Ability to assess situations and develop appropriate solutions;
▪ Demonstrates good judgment in selecting methods and techniques for obtaining solutions;
▪ Supporting Clinical Operations, elaborating or adapting methods and procedures on new studies for Clients, when needed;
▪ Ability to analyze if a determinate SOPs for Pharmacovigilance area is necessary;
▪ Good knowledge of Quality Assurance processes, activities;
▪ Proficiency in Microsoft Office and PV/Safety databases;
▪ Reliable professional training;
▪ Solid knowledge of oral and written English;
▪ Desirable intermediate knowledge of oral and written Spanish