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Pharmacovigilance Officer

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

  • Supervise pharmacovigilance case management outsourced to assigned platform(s)
  • Respond to case-related emails and inquiries from external service providers
  • Monitor case processing timelines and investigate any delays in reporting or transmission
  • Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
  • Support the review and validation of clinical study case narratives for inclusion in study reports
  • Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
  • Oversee reconciliation of cases with clinical databases managed by outsourced providers
  • Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

Job Skills

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Biostatistician

posted by: spj_bot

About the Role

Excelya is seeking a skilled Biostatistician to join our dedicated team, where Audacity, Care, and Energy shape our approach to clinical research. This is a fantastic opportunity for professionals looking to contribute their statistical expertise in a collaborative environment that values innovative solutions and fosters professional growth.

As a Biostatistician, you will play a crucial role in designing and analyzing clinical trials, using statistical principles to ensure the integrity and validity of our studies. You will work closely with cross-functional teams to generate insights that drive clinical decision-making and regulatory submissions.

Key Responsibilities:

Job Skills

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International RWE project manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.

We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As an external Global Evidence Generation manager, you will be responsible for the international management of several clinical studies (prospective Phase IV and / or epidemiological or retrospective studies) including Real World Evidence studies. You will contribute to the design of new projects defined portfolio strategy as well as the impactful communication of key results. The role requires a strong background in international and local study management, including the management of global Clinical Research Organizations, central medical review, statistical interpretation.

Main Responsibilities:

Job Skills

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Principal Medical Writer

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsabilities :

Job Skills

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Senior Redaction and Public Disclosure Specialist

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Writing department. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth

Main Responsibilities

  • Perform redaction and anonymisation of clinical documents (CSRs, Protocols, IBs) and ensure consistency, quality, and auditability.
  • Prepare, format, and submit documents for public disclosure portals (EMA, Health Canada).
  • Coordinate timelines and deliverables across multiple projects; ensure on-time completion.
  • Collaborate with cross-functional teams (Medical Writing, QA, Regulatory, Biostats, Data Management, Clinical) and interact with clients as needed.
  • Train, mentor, and provide backup support to RPDS team members; review and approve their redaction work.
  • Support project management, sponsor communication, and contribute to SOPs, processes, and financial offer preparation.

Requirements

About You

Job Skills

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Principal Medical Writer USA

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsabilities :

Job Skills

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Statistical Programmer

posted by: spj_bot

About the Role

Excelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.

As a Statistical Programmer, you will leverage your expertise to analyze and interpret complex clinical data, ensuring our studies meet the highest standards of quality and compliance. This role not only allows you to showcase your programming skills but also provides the opportunity to collaborate with a diverse group of professionals committed to making a tangible impact in healthcare.

Key Responsibilities:

Job Skills

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CRA Manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are seeking a highly motivated and experienced Clinical Research Associate (CRA) Manager to lead our dedicated team of CRAs. In this role, you will be responsible for overseeing clinical trial activities and ensuring compliance with regulatory requirements while fostering a culture of excellence and collaboration within the team.

Main Responsibilities

Job Skills

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Clinical Trial Assistant

posted by: spj_bot

About the Job

Step into the world of clinical research with Excelya as a Clinical Trial Assistant. Here at Excelya, our values of Audacity, Care, and Energy not only shape our company culture but also your experience as an employee. This role offers you a unique opportunity to be involved in the critical processes of clinical trials while collaborating with a team that is dedicated to making a difference.

Main Responsibilities

Job Skills

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Clinical Research Associate - Oncology

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations, particularly in the field of Oncology. As a Clinical Research Associate specializing in this area, you will play a crucial role in ensuring the successful conduct of oncology clinical trials, while supporting innovative cancer therapies that make a real difference in patients' lives.

Main Responsibilities:

Job Skills

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