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Pharmacovigilance Assistant

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Oracle

2mo ago

  • Internship
    Full-time
    Off-cycle Internship
  • Legal
    Research & Development
  • Reading
    Remote

AI generated summary

  • You need an undergrad in a relevant field, initial Pharmacovigilance experience, English fluency, strong multitasking and prioritization skills, excellent organization, and IT proficiency.
  • You will support pharmacovigilance operations, manage data and communications, complete adverse event forms, maintain compliance, conduct audits, and assist with training and documentation.

Requirements

  • An undergraduate degree in administration, clinical research, pharmacy, or related field;
  • Initial experience in Pharmacovigilance;
  • Fluency in English
  • The ability to multi-task and perform well under-pressure with tight deadlines;
  • Strong prioritization skills;
  • Excellent organizational skills and attention to detail;
  • Excellent IT skills (Pack Office).

Responsibilities

  • Provide administrative support (communication and mail handling, meeting coordination and report preparation)
  • Manage the general “Pharmacovigilance" mailbox(es)
  • Test online questionnaires from a safety perspective
  • Review incoming data daily to identify potential adverse events
  • Complete and submit adverse event forms in line with set deadlines
  • Ensure the proper filing and archiving of files in accordance with local, global and European regulations for both pharmacovigilance and GDPR compliance
  • Create and maintain dashboards
  • Assist with the organization of training sessions for internal and external stakeholders
  • Maintain standard procedures for ongoing Pharmacovigilance activities
  • Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and suggests recommendations for changes
  • Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies with some guidance based on complexity
  • Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections
  • Respond to security and/or compliance related requests and RFPs
  • Update and maintain internal and externally facing security documentation
  • Facilitate 3rd party audit activities
  • Maintain and track required compliance and security training for the GBUS
  • Maintain and update security and compliance reporting
  • Facilitate vendor security assessments as needed
  • Assist in managing security and/or quality, and compliance related projects for the GBUs

FAQs

What is the primary role of a Pharmacovigilance Assistant?

The primary role of a Pharmacovigilance Assistant is to provide administrative support in managing adverse event reports, testing online questionnaires, and ensuring compliance with pharmacovigilance regulations.

What qualifications are necessary for this position?

An undergraduate degree in administration, clinical research, pharmacy, or a related field is necessary, along with initial experience in Pharmacovigilance.

Is fluency in English required for this job?

Yes, fluency in English is required for effective communication in this role.

Are there opportunities for career growth in this position?

Yes, there are continuous learning and development opportunities that can advance your career within the company.

What kind of training does Oracle provide for new employees?

Oracle provides world-class onboarding and training to prepare new employees for making an impact in their roles.

How does Oracle promote work-life balance?

Oracle promotes work-life balance by offering flexible and remote working options for employees.

What benefits are offered to employees in this position?

Employees can expect a competitive salary, exciting benefits, a supportive work culture, and opportunities to give back to their communities through volunteer programs.

Is experience in Pharmacovigilance mandatory for applying?

While initial experience in Pharmacovigilance is preferred, it may not be strictly mandatory depending on the applicant's other qualifications.

What are the daily responsibilities of a Pharmacovigilance Assistant?

Daily responsibilities include managing the Pharmacovigilance mailbox, reviewing incoming data for adverse events, completing adverse event forms, and assisting with training sessions.

Does Oracle have a commitment to diversity and inclusion?

Yes, Oracle is committed to promoting an inclusive workforce that values diversity and provides equal employment opportunities for all.

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Oracle

Information Technology & Services

Technology
Industry
10,001+
Employees
1977
Founded Year

Mission & Purpose

We’re a cloud technology company that provides organizations around the world with computing infrastructure and software to help them innovate, unlock efficiencies and become more effective. We also created the world’s first – and only – autonomous database to help organize and secure our customers’ data. Oracle Cloud Infrastructure offers higher performance, security, and cost savings. It is designed so businesses can move workloads easily from on-premises systems to the cloud, and between cloud and on-premises and other clouds. Oracle Cloud applications provide business leaders with modern applications that help them innovate, attain sustainable growth, and become more resilient. The work we do is not only transforming the world of business--it's helping defend governments, and advance scientific and medical research. From nonprofits to companies of all sizes, millions of people use our tools to streamline supply chains, make HR more human, quickly pivot to a new financial plan, and connect data and people around the world. At work, we embrace diversity, encourage personal and professional growth, and celebrate a global team of passionate people developing innovative technologies that help people and companies tackle real-world problems head-on.