About the role

Aplyr's Quick Take

This role involves coordinating and compiling data for Periodic Safety Update Reports (PSURs) in the pharmaceutical sector. You'll be working closely with various teams to ensure timely completion and compliance with regulations, making it more of a support role than a creative one.

Good fit

Ideal candidates are detail-oriented individuals with a background in medical writing or regulatory affairs, likely with a few years of experience. Strong communication skills and the ability to manage timelines are essential.

Worth noting

The position emphasizes compliance and communication with multiple stakeholders, which can be a red flag for those who prefer independent work. The role is also situated in a global company, offering potential exposure to international standards and practices.

About Clinchoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Description

Primary Responsibilities:

• Responsible for the coordination and compilation of the relevant data to complete a PSUR.

• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules.

• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Skills & Tags

ai data product

Aplyr's read

ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
Synthesized from recent postings & public sources

What's promising

•ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
•The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
•ClinChoice's global presence allows employees to engage with international projects and clients.

What to watch

•Limited public information about ClinChoice's workplace culture and employee satisfaction.
•The company may face competition from larger CROs with more established reputations.
•Potential candidates might find limited career advancement information publicly available.

Why ClinChoice

•ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
•The company has a strong emphasis on statistical programming and regulatory affairs roles.
•ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ClinChoice

ClinChoice

clinchoice.com

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ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.