Drug Safety Specialist at Parexel
| Position | Drug Safety Specialist |
|---|---|
| Company | Parexel |
| Experience Required | 1 – 4 Years |
| Salary Range | 4 – 7 Lacs Per Annum |
| Location | Hyderabad |
| Educational Requirements | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences |
| Application Mode | Online |
| Key Responsibilities | ICSR Management, Signal Detection, Regulatory Submissions |
| Skills Needed | PV Software, MedDRA, WHO Drug Dictionary, Attention to Detail |
| Work-Life Benefits | Flexibility, Work/Life Balance, Time Management |
Join Parexel as a Drug Safety Specialist in Hyderabad
If you’re passionate about pharmacovigilance and drug safety, Parexel is looking for skilled professionals to join their team in Hyderabad. In this role, you’ll be a key part of ensuring drug safety compliance across clinical trials and post-marketing activities. The position offers a competitive salary, opportunities for growth, and the chance to work with a globally recognized organization committed to innovation and patient safety. Drug Safety Specialist at Parexel
Responsibilities of a Drug Safety Specialist
ICSR Management
Your primary responsibility will be to process Individual Case Safety Reports (ICSRs) from various sources. You’ll need to ensure that these reports are handled with precision and comply with both local and international regulatory requirements. Additionally, you’ll perform literature searches to identify case reports that are relevant for safety monitoring and inclusion in databases.
Another critical aspect of your role will be signal detection—identifying potential safety concerns that could impact patient well-being. You’ll also track regulatory information to ensure timely submissions to global health authorities and assist in preparing aggregate reports for studies. Drug Safety Specialist at Parexel
Compliance & Quality Monitoring
As a Drug Safety Specialist, you will help maintain high standards of quality and compliance. This involves conducting quality reviews of ICSRs to ensure they meet the guidelines set by regulatory authorities, such as the International Conference on Harmonisation (ICH). You’ll play an important part in generating metrics for regulatory submissions and investigating any instances of delayed case reporting.
Staying compliant with local and international regulations is vital, and you’ll be responsible for making sure all activities align with Standard Operating Procedures (SOPs). Drug Safety Specialist at Parexel
Medical and Product Dictionary Management
In some cases, you will oversee Medical Dictionary (MedDRA) and product dictionary management activities. Knowledge of MedDRA is particularly beneficial as it helps streamline reporting and ensures consistent terminology across all drug safety processes. Drug Safety Specialist at Parexel
Required Qualifications and Skills
Educational Background
The ideal candidate should hold a Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or Medical Sciences. A solid educational foundation is essential for understanding the complex nature of pharmacovigilance and drug safety.
Experience
While this position is open to individuals with 1-4 years of experience, those with specific experience in pharmacovigilance (PV) or drug safety operations will have an advantage. Familiarity with handling ICSRs and making regulatory submissions will be extremely valuable in your day-to-day responsibilities. Drug Safety Specialist at Parexel
Technical Skills
You’ll need experience using pharmacovigilance software tools for case processing and reporting. Knowledge of MedDRA and the WHO Drug Dictionary is also advantageous. Additionally, if you have experience in literature screening and signal detection, you’ll be well-prepared to excel in this role. Drug Safety Specialist at Parexel
Soft Skills
Excellent communication and interpersonal skills are critical to succeed in this fast-paced, regulatory-focused environment. You should be able to work efficiently under tight deadlines, and possess strong problem-solving abilities and attention to detail. These soft skills will enable you to handle complex safety reports while ensuring compliance and maintaining high-quality standards. Drug Safety Specialist at Parexel
Why Join Parexel?
Parexel is a global leader in healthcare solutions, offering a dynamic work environment where innovation meets patient care. As a Drug Safety Specialist, you’ll be at the forefront of ensuring the safety of new drugs and therapies, contributing to global health and well-being.
Not only does Parexel provide opportunities for career growth, but the company also prioritizes work-life balance, offering flexible working hours to help employees manage their professional and personal lives. This role also promises ample room for learning and development, especially for those interested in moving up in the field of pharmacovigilance. Drug Safety Specialist at Parexel
If you’re ready to make a difference in the world of drug safety and have the necessary qualifications and skills, this is the perfect opportunity for you. Apply today and take the next step in your career with Parexel!