Regulatory Affairs Associate (Scandinavia) - IQVIA Biotech (R1099838) in Solna, Sweden at IQVIA™

Date Posted: 11/17/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Solna, Sweden
  • Experience:
    Not Specified
  • Date Posted:
    11/17/2019
  • Job ID:
    R1099838

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

BASIC FUNCTION:

Assists with delivery of Safety and Regulatory services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.  

Primary responsibilities include review, preparation and submission of regulatory safety reports (including expedited and periodic) to all applicable Regulatory Authorities, Ethics Committees, Institutional Review Boards (IRBs) and Investigators within defined timelines.  

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assists with and prepares safety reports for submission to Sponsors, Regulatory Authorities, Ethics Committees, IRBs and Investigators as applicable.
  • Liaise with relevant internal departments to ensure timely submission of expedited and periodic reports to applicable Regulatory Authorities, Ethics Committees, IRBs and Investigators.
  • Responsible for updating and maintaining Regulatory Submission tracker for assigned projects in collaboration with other internal departments such as Clinical and ISSC.
  • Assists with SAE reconciliation as needed.
  • Attends internal and client project team meetings and provides relevant team updates as required.
  • Assists with vendor compliance for third party organizations that perform regulatory safety reporting on behalf of IQVIA Biotech/Sponsor.
  • Assists with performing project related study close-out and archival tasks.
  • May assist management in writing processes and developing documents related to Regulatory Safety reporting, including study-specific processes.
  • Assists with developing and maintaining tracking reports related to progress of studies, communicating regularly with Safety Reporting Specialist and team on status of activities.
  • Assists in the collection and maintenance of Safety Submission Regulatory Intelligence for the IQVIA Biotech Regulatory Safety
  • Provides general administrative support to projects as requested (e.g., taking minutes, copying, filing, faxing, scheduling).
  • May mentor and/or train new Regulatory staff.
  • Performs other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Good written and verbal communication skills.
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Regulatory department activities.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with oversight.
  • Basic knowledge of medical terminology.
  • Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Strong time management skills.
  • 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.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree in one of the life sciences or clinical research and a minimum of 1 year of related clinical research experience.
  • Equivalent combination of relevant education and experience.
  • Prior experience in clinical trial safety preferred.
  • Basic understanding of the principles of regulatory safety reporting
  • Some experience of regulatory safety reporting preferred, but not essential
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required.
  • Good written and verbal communication skills required.
  • Good interpersonal and organization skills required.
  • Ability to work independently, prioritize effectively and work within a matrix team environment required.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1099838