Safety Specialist, Mexico, Home-based

hace 2 semanas

Desde casa, México IQVIA A tiempo completo

**_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

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