IQVIA Biotech India Jobs – Life Sciences Safety Specialist Vacancy
IQVIA Biotech India Jobs – Life Sciences Safety Specialist Vacancy. IQVIA Life Sciences Safety Specialist Job. For more details on the Job description, responsibilities and such, check out all the details posted below.
Job Title: Safety Specialist – IQVIA Biotech India (Homebased)
Primary Location: Bangalore, India
Employment Term: Full time
Job ID: R1188484
- Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project-specific procedures.
- Primary responsibilities consist of processing and reporting incoming safety events and also related data.
- May serve as Safety Management Lead on small to moderate-sized studies that are simple to moderate in complexity and scope of work with support from senior staff.
ESSENTIAL JOB FUNCTIONS, DUTIES AND ALSO RESPONSIBILITIES:
- Performs safety case processing tasks including, however not restricted to:
♦ Intake and also triage tasks as applicable for assigned projects
♦ Reviewing incoming safety info for completeness and accuracy
♦ Tracking and data entry
♦ Writing clinical narratives
♦ Generating queries
♦ Contacting sites for missing and/or unclear info
♦ QC of cases and provide feedback as appropriate
♦ Generating regulatory reports
♦ Generating metrics
- May serve as Safety Management lead or back-up lead on small to moderate sized studies that are simple to moderate in complexity and also scope of work with guidance from senior staff. Responsibilities include, yet are not limited to:
♦ All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.
♦ Attendance at team and client meetings
♦ Mentoring of staff on safety processes
- In collaboration with 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 defences or other presentations.
- May mentor and/or train new Safety Management staff.
- Communication with the client or internal stakeholders as applicable.
- Performs other related duties as assigned or requested by department Management.
KNOWLEDGE, SKILLS AND ALSO CAPABILITIES:
- In depth knowledge of clinical research process and also medical terminology.
- Able to identify, analyze and problem solve moderately complex issues and also trends with guidance and also support from senior staff.
- Outstanding written and also verbal communication skills. Able to express complex ideas.
- Positive attitude and also 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.
- Able to develop knowledge of protocol, regulatory requirements and also company SOPs.
- Familiar with matrix team structure and phases of research. Able to identify and document regulatory non-compliance and also any issues involving subject safety.
- Good organizational and interpersonal skills.
- Ability to reason independently to assess and also recommend specific solutions in a clinical setting.
- Attention to detail. Able to identify and resolve discrepancies on SAE reports and also case report forms.
- Understands electronic data capture including basic data processing functions.
- Understands current ICH/ GCP standards 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 kind of difficulties in establishing priorities.
- Identifies personal career development goals and opportunities connected to current job.
- Solicits and also applies performance feedback.
- Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and also flexibility with changes in responsibilities and also duties.
- Demonstrates honesty and also 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 instead of placing blame.
- Establishes and also maintains effective relationships with customers (internal and also external) and also gains their trust and respect. Provides customers with complete and accurate info. 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.
- Capability 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.
- Equivalent combination of pertinent education and experience.
- Computer literacy and also experience working with Microsoft Office (Word, Excel) required.
- Knowledge of electronic data capture preferred.
- Outstanding verbal and also written communication skills required.
- Excellent interpersonal and also organizational skills required.
- Capability to work independently, prioritize effectively and also work in a matrix team environment required.
- Capability and also willingness to travel domestically and also internationally as required; capability to rent an automobile.
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