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Drug Safety Associate Consultant

Open 65d posting dated 2 months ago

Job Description

Job Title: Senior Executive / Specialist - Case Processing

Employment Type: Contract

Location: Brazil (Remote)

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.

Primary Responsibilities:

  • Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
  • Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database.
  • Experience in ARGUS database.
  • Experience in rare disease portfolio.
  • Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
  • Training and mentoring skill (ICSR, Safety database etc.).

Candidate Profile:

  • Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
  • Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
  • Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
  • Must be able to Write and speak Japanese.
  • Dynamic working hours.

What this application asks

greenhouse

First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location

  • LinkedIn Profile optional
  • Website optional
  • Are you legally authorized to work in the country that you are being hired? choose one
  • If "yes", will you now or in the future require sponsorship to work in the country that you are being hired? choose one
  • What type of employment are you seeking? choose any
  • Area of expertise - Therapeutic area or other skills written answer · optional
  • Have you previously worked for ClinChoice or its subsidiaries? If yes, please provide additional details written answer · optional
  • Do you have a friend or family member working for ClinChoice? If yes, please provide additional details. written answer · optional
  • Are you currently employed? choose one
  • Current Address optional
  • Country choose one
  • Will you relocate if the job requires it? choose one
  • Date available to work? written answer
  • Employment History: Please list your two most recent employers, including name of the company, job title, and dates employed written answer
  • Are you willing to undergo a background check upon employment? choose one
  • If hired, can you furnish proof you are eligible to work in the country you are being hired? choose one
  • How did you hear about this opening? choose one
  • How much are you willing to travel? choose one
  • Are you ok to work in a hybrid model work schedule? choose one
  • What is your desired salary/hourly rate? written answer
  • Which languages are you proficient in? written answer
  • Please read and accept our privacy policy: choose one
  • Contact Preferences: Email choose one
  • Contact Preferences: Phone choose one
  • Contact Preferences: Text choose one

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