Parexel

Patient Safety Associate II

Parexel  •  Hyderabad, IN (Remote)  •  2 hours ago
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Job Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Patient Safety Associate II

Key Responsibilities

  • Process and manage Individual Case Safety Reports (ICSRs) including data entry, case assessment, MedDRA coding, narrative writing, follow-up, reconciliation, and quality checks.
  • Support regulatory safety submissions, periodic reports, and compliance tracking to health authorities.
  • Conduct literature searches and screening to identify adverse events, safety signals, and reportable cases.
  • Coordinate with global affiliates on safety reporting, local compliance requirements, translations, and data exchange.
  • Assist with regulatory support activities, product registrations, safety database updates, and regulatory intelligence monitoring.
  • Ensure adherence to SOPs, regulatory timelines, quality standards, and client requirements.
  • Participate in audits, inspections, process improvements, metrics reporting, and training activities.
  • Collaborate with cross-functional teams and support client interactions as required.

Skills & Qualifications

  • Basic knowledge of Pharmacovigilance, drug safety regulations, ICH guidelines, and regulatory reporting.
  • Good understanding of medical terminology and safety databases.
  • Strong analytical, communication, organizational, and problem-solving skills.
  • Proficiency in MS Office and PV systems.

Education & Experience

  • Degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, Dentistry, or related field.
  • 4+ years of experience in Pharmacovigilance, safety case processing, or regulatory reporting preferred.
Parexel

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.

Community Guidelines

Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:

• Abusive, harassing or threatening to others.

• Defamatory, offensive, obscene, vulgar or depicting violence.

• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,

sexual preference or orientation, nationality or political beliefs.

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• Fraudulent, deceptive, libelous, misleading or unlawful.

• Referencing criminal or illegal activity.

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We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Raleigh, North Carolina
Year Founded
Unknown
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