Safety Specialist, Mexico, Home-based

**_IQVIA Biotech _**_is seeking a Clinical Safety Specialist with at least 2 years of clinical trial case processing experience working in Argus:_**BASIC FUNCTION**:- Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.- Primary responsibilities include Processing and Reporting of incoming safety events and related data.- Assists Safety Management Leads with select tasks as assigned with supervision.- May serve as Safety Management Lead or backup Lead on studies/programs that are simple to moderate in scope of work.**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:- Safety Case Processing tasks including, but not limited to:- Triaging tasks as applicable for assigned projects- Reviewing incoming safety information for completeness and accuracy- Tracking and data entry- Writing clinical narratives- Generating queries- Contacting sites for missing and/or unclear information- Performing QC of cases and document results as applicable- Generating regulatory reports- Support monitoring of the safety database workflow, ensuring that case report timelines and deliverables are met- Safety Management Lead tasks including but not limited to:- Assisting in Safety Management start-up process including development of Safety Management Plan, SAE form, etc.- Attendance at team and client meetings- Reconciliation- Generating metrics- In collaboration with study safety manager, supports compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager.- May assist with bid defenses or other presentations.- May mentor and/or train new Safety Management staff.- Communicates with the client or internal stake holders as applicable.- Performs other related duties as assigned or requested by department management.**KNOWLEDGE, SKILLS AND ABILITIES**:- In depth knowledge of clinical research process and medical terminology.- Able to identify, analyze and problem solve moderately complex issues and trends with guidance and support from senior staff.- Excellent written and verbal communication skills. Able to express complex ideas.- Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.- Able to develop knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.- Good organizational and interpersonal skills.- Ability to reason independently to assess and recommend specific solutions in a clinical setting.- Attention to detail. Able to identify and resolve discrepancies on SAE reports and case report forms.- Understands electronic data capture including basic data processing functions.- Understands current ICH/ GCP guidelines applicable to the conduct of clinical research.- Demonstrates professionalism and presents a positive image of the company.- Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.- Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.- Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.- Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.- Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.- Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.- Able to work independently and identify issues and solutions proactively with guidance and mentorship from senior level staff and/or Safety Management.**CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA**:- Very limited physical effort required to perform normal job duties.- Ability to travel domestically and internationally.**MINIMUM RECRUITMENT STANDARDS**:- Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.- Minimum of 2 years of experience in clinical trial safety processing.- Equivalent combination of relevant education and experience.- Computer literacy and experience working with a safety database (Argus preferred), Microsoft Office (Word, Excel) required.- Knowledge of electronic data capture preferred.- Excellent verbal and written communication skills re