[Remote] Remote Sr Pharmacovigilance Associate III

Other Jobs To Apply

Note: The job is a remote job and is open to candidates in USA. Planet Pharma is seeking a Sr Pharmacovigilance Associate III to support the Global Patient Safety Quality Management System. The role involves developing and maintaining safety procedural documentation and ensuring compliance with global regulatory requirements.


Responsibilities

  • Support GPS procedural document management activities including the creation, review, and revisions of controlled documents, policies and procedures and the GPS PSMF process.
  • Support the maintenance of the Global PSMF, local PSMFs and annexes on a regular basis to ensure that content accurately reflects BeiGene PV processes and compliance with regulatory requirements in an expedited manner.
  • Ensures high service level to GPS stakeholders by advising on both PSMF and document strategy for GPS teams and supports content development for the PSMF and specific procedures across multidisciplined teams.
  • Leads procedural document development across the multidisciplined teams and ensure adequate input from cross-functional GPS groups and external business functions.
  • Actively ensures collaboration with GPS management, subject matter experts and other functions to develop or revise SOPs and procedural documents and ensures adequate input from business functions.
  • Identifies, supports to actively resolve and escalate procedural document-related issues.
  • Leads in global harmonization of procedural documents to ensure clarity of content, consistency in application of BeiGene documentation hierarchy and its conventions.
  • Support the end-to-end management of Global and/or Local PSMFs, including data collection, timely receipt of data and supporting documentation for quality control, Veeva workflow management, query resolution and follow-up, logbook generation, and PSMF formatting and publishing.
  • Responsible for reviewing PSMF data and ensuring the application of internal core PSMF strategy, to ensure correct data inclusion
  • Responsible for conducting timely quality control checks for each PSMF contribution, including but not limited to PSMF Narrow Reviews and PSMF Consistency Checks for Global and Local PSMF.
  • Participating and supporting in Audits and Inspections as a PSMF SME.
  • Maintains oversight of local PSMFs and variations and deviation to the Core PSMF due to local regulations.

Skills

  • Five years or more of experience in pharmacovigilance in operational roles, has a deep understanding of pharmacovigilance and regulatory requirements & processes.
  • Minimum three years of experience of PV quality management, standards and PSMF maintenance.
  • Demonstrated experience with implementing cross-functional partnerships and business processes.
  • Strong command of global pharmacovigilance requirements.
  • Proficient in Veeva Quality.
  • Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience.
  • Advanced Life Sciences Degree a plus.

Company Overview

  • Planet Pharma is a pharmaceuticals company. It was founded in 2009, and is headquartered in Northbrook, Illinois, USA, with a workforce of 1001-5000 employees. Its website is

    • Company H1B Sponsorship

  • Planet Pharma has a track record of offering H1B sponsorships, with 3 in 2022, 5 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.

    • Back to blog

    Common Interview Questions And Answers

    1. HOW DO YOU PLAN YOUR DAY?

    This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

    2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

    When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

    3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

    Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

    4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

    With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

    5. HOW DO YOU PROCESS INFORMATION?

    Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

    6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

    Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

    7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

    Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

    8. HOW TO PRIORITIZE WORK?

    The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

    9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

    Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

    10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

    This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

    Related Posts

    Data Entry Question and Answer

    $150 $49

    Remote Question and Answer

    $150 $49

    Virtual Assistant Question and Answer

    $150 $49

    Content Moderator Question and Answer

    $150 $49

    Customer Service Question and Answer

    $150 $49

    Video Game Tester Question and Answer

    $150 $49