Parexel Icon Hiring for Drug Safety Associate II
Position: Drug Safety Associate II
Company: Parexel Icon
Location: Mohali, Punjab, India
Industry: Clinical Research Organization (CRO)
Employment Type: Full-Time
Work Mode: Online Application
Experience Required: Minimum 2 Years
Salary Range: ₹5 – ₹7 LPA
Application Deadline: April 16, 2025
Education Requirements: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, or a degree in Life Sciences, Medical, Dentistry, Physiotherapy, or Nursing
Status: Verified Job Opening
About Parexel
Parexel is a globally recognized Clinical Research Organization (CRO) dedicated to advancing global health through innovation in clinical trials, regulatory consulting, and market access strategies. With a deep-rooted commitment to patient safety and the development of life-changing medicines, Parexel works alongside biopharmaceutical clients to bring therapies from lab to life.
Known for its patient-first approach and scientific excellence, Parexel fosters a collaborative environment where every employee’s contribution plays a critical role in improving lives across the globe. Parexel Icon Hiring for Drug Safety Associate II
Position Overview: Drug Safety Associate II
As a Drug Safety Associate II, you will be an essential part of the pharmacovigilance team, contributing to the safety assessment of drugs in both clinical trial and post-marketing settings. Your work will support the collection, analysis, and reporting of safety data to ensure regulatory compliance and patient safety. The role offers the opportunity to engage in challenging projects, enhance your technical and analytical skills, and collaborate with industry experts in a highly regulated environment. Parexel Icon Hiring for Drug Safety Associate II
Roles and Responsibilities
Case Processing and Safety Reporting
- Process Individual Case Safety Reports (ICSRs) originating from spontaneous sources, clinical trials, literature, and other post-marketing settings.
- Assist in literature surveillance activities and signal detection for safety signals and trends.
- Conduct regulatory tracking and manage the timely submission of safety reports.
- Support the preparation of aggregate safety reports like Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Parexel Icon Hiring for Drug Safety Associate II
Compliance and Quality Assurance
- Ensure that all safety cases and reports comply with local and international regulatory requirements, including ICH, FDA, and EMA standards.
- Perform quality checks on safety data and narrative summaries.
- Generate compliance metrics and contribute to the investigation of late cases and other compliance issues.
Database and Documentation Management
- Collaborate with technical teams to ensure correct safety database setup.
- Participate in the preparation of data entry guidelines and user acceptance testing (UAT) for system updates or new implementations.
- Handle electronic documentation and contribute to case narrative writing and query resolution.
Regulatory and Medical Support
- Assist in the implementation and management of expedited reporting procedures to global regulatory authorities.
- Provide administrative support to Medical Directors and Safety Physicians for medical monitoring during clinical trials.
Audits, Inspections, and Training
- Participate in internal and external audits to ensure ongoing compliance with SOPs and regulatory expectations.
- Attend ongoing pharmacovigilance and drug safety training programs.
- Join client meetings and contribute to continuous process improvement and client satisfaction.
- Parexel Icon Hiring for Drug Safety Associate II
Educational Qualifications
Applicants must hold one of the following qualifications:
- Bachelor’s or Master’s Degree in Pharmacy (B.Pharm or M.Pharm)
- Doctor of Pharmacy (Pharm.D)
- Degree in Life Sciences such as B.Sc or M.Sc
- Degree in Medicine, Dentistry, Physiotherapy, or Nursing, preferably with clinical or patient care exposure
Required Experience and Skills
Professional Experience
- A minimum of 2 years of hands-on experience in pharmacovigilance or drug safety is essential.
- Strong experience in ICSR case processing, literature search activities, and regulatory safety submissions.
- Parexel Icon Hiring for Drug Safety Associate II
Key Competencies
- Analytical thinking with a detail-oriented mindset.
- Excellent verbal and written communication skills.
- Strong organizational and time management capabilities.
- Proficiency with safety databases and pharmacovigilance tools.
- Ability to collaborate in a client-focused, team-based setting.
- Familiarity with industry guidelines (ICH, MedDRA, WHO Drug Dictionary, etc.) and global regulatory safety reporting requirements.
Why Choose Parexel?
Global Impact
Work on international projects that contribute to the development and delivery of life-saving drugs and therapies.
Career Development
Parexel offers various professional development pathways and training opportunities, encouraging employees to grow within the organization.
Collaborative Work Culture
Join a team of highly skilled professionals and work in a nurturing environment that values expertise, innovation, and compassion.
Work-Life Balance and Benefits
Enjoy competitive compensation, health and wellness benefits, insurance, and policies designed to promote work-life balance and employee satisfaction.
Parexel Icon Hiring for Drug Safety Associate II
How to Apply
Interested and qualified candidates can apply online by visiting Parexel’s official career page or through authorized job portals. Ensure your resume is updated with relevant pharmacovigilance experience, educational qualifications, and contact details.
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For individuals passionate about drug safety and patient welfare, this is a significant opportunity to make a difference. Join Parexel in its mission to improve health outcomes around the world. Parexel Icon Hiring for Drug Safety Associate II