PAREXEL Hiring for Drug Safety Specialist at – Life Sciences, Pharmacy Apply
Introduction
PAREXEL is a leading global biopharmaceutical service provider that supports the biotechnology and pharmaceutical industries in the development of new drugs and treatments. Specializing in contract research, medical communications, and consulting services, PAREXEL operates across a broad range of therapeutic areas to assist pharmaceutical, biotechnology, and medical device companies worldwide.
Currently, PAREXEL is hiring Drug Safety Specialists for its Mohali location. This is an excellent opportunity for candidates with a background in life sciences, pharmacy, or biomedical sciences to work in a dynamic and regulated pharmacovigilance environment.
Job Details and Responsibilities
Position Overview
- Job Title: Drug Safety Specialist
- Location: Mohali, India
- Industry: Medical Sciences, Pharmacovigilance
- Application Deadline: 28th February 2025
Primary Responsibilities
Core Job Purpose
The Drug Safety Specialist will be responsible for providing technical and process-related support in clinical trials and post-marketed drug safety management. Key duties include:
- Ensuring compliance with drug safety regulations and Standard Operating Procedures (SOPs).
- Processing Individual Case Safety Reports (ICSRs) from various sources.
- Conducting literature searches and reviews.
- Supporting regulatory submissions and preparing aggregate safety reports.
- Managing medical product dictionaries where applicable.
General Responsibilities
- Maintaining a strong working knowledge of assigned drug safety profiles.
- Organizing work to comply with global regulatory reporting obligations.
- Developing project-specific safety workflows, templates, and procedures.
- Attending internal and client-specific training sessions.
- Assisting with audits, inspections, and compliance metrics.
- Delegating tasks to Drug Safety Assistants.
- Collaborating with client teams to ensure high-quality deliverables.
- Identifying and reporting areas of concern to senior management.
- Mentoring new recruits as needed.
Key Areas of Expertise
Case Processing & Pharmacovigilance Support
- Monitoring incoming safety reports from various sources.
- Validating, triaging, and processing Individual Case Safety Reports (ICSRs).
- Reviewing medical coherence and completeness of reports.
- Entering validated cases into pharmacovigilance safety databases.
- Conducting MedDRA coding and causality assessments.
- Preparing case narratives and routing cases for further review.
- Performing quality checks and validation for accuracy.
Regulatory Compliance & Drug Safety Reporting
- Managing local and global drug safety reporting requirements.
- Registering with regulatory authorities for electronic submissions.
- Submitting safety reports to relevant stakeholders.
- Unblinding Suspected Unexpected Serious Adverse Reactions (SUSARs) as required.
- Ensuring compliance with global pharmacovigilance reporting obligations.
Literature Search & Signal Detection
- Conducting literature reviews to identify adverse drug reactions (ADRs).
- Developing and updating search strategies for accurate literature retrieval.
- Reviewing scientific articles and regulatory reports.
- Ensuring database thesauri updates align with evolving search strategies.
Candidate Profile & Qualifications
Educational Qualifications
Candidates should have a degree in one of the following fields:
- Life Sciences
- Health or Biomedical Sciences
- Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics
A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is an added advantage.
Experience Requirements
- Minimum 4 years of experience in drug safety/pharmacovigilance.
- Strong knowledge of medical terminology and drug development processes.
- Prior experience in data analysis and evaluation of safety data.
Essential Skills
- Proficiency in drug safety regulations and compliance.
- Strong analytical and problem-solving skills.
- Expertise in literature/database searches.
- Effective verbal and written communication.
- Ability to work collaboratively in a team environment.
- Proficiency in MS Office and web-based applications.
Why Join PAREXEL as a Drug Safety Specialist?
- Reputable Global Organization: Work with a renowned clinical research organization.
- Career Growth: Opportunities for advancement in pharmacovigilance and drug safety.
- Competitive Salary & Benefits.
- Exposure to International Regulatory Standards: Work on global compliance requirements.
How to Apply?
Interested candidates can apply online through PAREXEL’s official website before 28th February 2025.
APPLY HERE
FAQs
1. What is the salary range for a Drug Safety Specialist at PAREXEL?
While the salary varies based on experience, PAREXEL offers competitive compensation aligned with industry standards.
2. Is prior experience mandatory for this role?
Yes, a minimum of 4 years of experience in drug safety or pharmacovigilance is required.
3. What educational background is needed?
A degree in Life Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, or other Biomedical Sciences is essential.
4. Are freshers eligible to apply?
No, this role requires prior work experience in pharmacovigilance.
5. What is the job location?
The position is based in Mohali, India.
6. What does the recruitment process involve?
The recruitment process typically includes screening, technical interviews, and final HR discussions.
For more details, visit PAREXEL’s official website.
To Join In Whatsapp group Click below Link
https://chat.whatsapp.com/ERzsuXoDDnOLBZ3spkddn5
To Join Telegram Channel Click Below Link
https://t.me/careerpathwayjobs
To know the Latest Job updates click below Link
Career Pathway – Guide to your success
