Are you looking for a challenging and rewarding career in the pharmaceutical industry? PAREXEL, a global leader in biopharmaceutical services, is seeking a talented Drug Safety Specialist to join their team in Mohali. This role is essential for ensuring the safety and efficacy of new drugs and treatments through rigorous drug safety management and compliance with global regulatory standards.
Job Purpose and Responsibilities
As a Drug Safety Specialist at PAREXEL, your primary responsibility will be to provide technical and process support for drug safety management during clinical trials and post-marketing activities. You will play a key role in processing Individual Case Safety Reports (ICSRs) from various sources, performing literature searches, signal detection, and regulatory submissions. You will help maintain compliance with relevant regulations and Standard Operating Procedures (SOPs), ensuring the welfare of patients and the integrity of the pharmaceutical process.
Key Responsibilities:
- Monitor incoming reports from various sources, ensuring completeness and validity.
- Conduct literature searches and reviews for signal detection.
- Process ICSR compliance and quality assurance, including late case investigations.
- Collaborate with cross-functional teams to prepare aggregate reports and assist in audits and inspections.
- Mentor new team recruits and lead training sessions to enhance team capabilities.
Candidate Profile
PAREXEL is looking for candidates who possess the following qualifications and experience:
- A degree in Life Sciences, Health, or Biomedical Sciences such as Pharmacy, Microbiology, Biochemistry, Biotechnology, or equivalent work experience in Pharmacovigilance.
- At least 4 years of relevant experience in drug safety or pharmacovigilance, with a strong understanding of medical terminology.
- Experience or a degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is an added advantage.
Desired Skills:
- Strong knowledge of the drug development process and global safety regulations.
- Excellent analytical skills and the ability to evaluate safety data effectively.
- Proficient in database/literature searches with sound knowledge of the regulatory submission processes.
- Outstanding interpersonal, verbal, and written communication skills.
- Ability to manage multiple tasks efficiently while maintaining attention to detail.
Why Work at PAREXEL?
PAREXEL is committed to fostering a collaborative and supportive work environment. The organization prides itself on its commitment to professional development and has a robust training program in place. As a Drug Safety Specialist, you will be part of a highly skilled team dedicated to ensuring the safety of drugs and treatments worldwide.
In addition, PAREXEL offers competitive salaries, benefits packages, and opportunities for career advancement. Being part of a global leader in the biopharmaceutical space provides an enriching experience that can significantly impact your professional growth.
Application Process
If you meet the qualifications and are interested in applying for the Drug Safety Specialist position at PAREXEL, please submit your application by February 28, 2025. Don’t miss the opportunity to contribute to the development of life-saving treatments and services on a global scale.
