Job Opportunity: Patient Safety Associate I (Pharmacovigilance)
Location: Mohali, India
Company: Parexel
Job Summary
Parexel is seeking a detail-oriented and motivated individual to join our team as a Patient Safety Associate I in Mohali. This is an ideal role for freshers and early-career professionals looking to establish a career in the pharmaceutical industry. You will play a vital role in our global pharmacovigilance operations by supporting clinical trials, managing drug safety data, and ensuring strict adherence to regulatory compliance. If you are passionate about patient safety and eager to grow within a leading global Contract Research Organization (CRO), we invite you to apply.
Responsibilities
As a Patient Safety Associate I, your primary objective is to ensure the accurate processing and reporting of safety data. Your daily duties will include:
Pharmacovigilance & ICSR Processing
- Monitor safety mailboxes and literature sources for new reports.
- Perform Individual Case Safety Report (ICSR) data entry, case creation, and workflow management.
- Conduct MedDRA coding to ensure clinical accuracy.
- Prepare medically coherent case narratives and Adverse Drug Reaction (ADR) forms.
- Execute quality checks and data validation to maintain high standards of accuracy.
Safety Reporting & Compliance
- Submit ICSRs to regulatory authorities and key stakeholders within defined timelines.
- Manage late case investigations and track compliance metrics.
- Support expedited reporting procedures to meet global safety standards.
- Maintain comprehensive safety documentation to ensure audit readiness.
Literature Review & Signal Detection
- Perform systematic literature searches based on defined strategies.
- Assist in identifying potential safety signals and ADRs.
- Conduct peer reviews of literature screening results.
- Maintain local journal databases and optimize search strategies.
Regulatory & Operational Support
- Assist with global regulatory submissions, including eCTD, PBRER, and RMP documentation.
- Coordinate with global affiliates for the seamless exchange of safety data.
- Maintain accurate regulatory intelligence databases.
- Adhere strictly to Standard Operating Procedures (SOPs) and project workflows.
- Participate in professional training, audits, and client-facing communication.
Requirements
To be considered for this position, candidates should possess the following qualifications and skills:
- Education: A degree in M.Pharm, B.Pharm, or M.Sc (Life Sciences, Microbiology, Biotechnology, or Biochemistry).
- Experience: Freshers are highly encouraged to apply. Prior exposure to healthcare or pharmacovigilance environments is an advantage.
- Knowledge & Skills:
- Foundational knowledge of Pharmacovigilance, ICH guidelines, and drug safety processes.
- Understanding of ICSR workflows.
- Strong analytical skills with a high degree of attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office Suite and aptitude for learning safety database software.
Benefits
Joining Parexel provides you with a robust platform for professional development. Our benefits include:
- Competitive Compensation: An estimated salary range of ₹3.5 LPA – ₹6 LPA.
- Professional Growth: Structured training programs in MedDRA, ICSR processing, and regulatory reporting.
- Global Exposure: Opportunity to work with international clients and engage with diverse regulatory frameworks.
- Career Advancement: A clear pathway to evolve into roles such as Drug Safety Associate, Safety Scientist, or Signal Detection Specialist.
- Collaborative Environment: Work within a global team at a leading CRO, fostering a strong culture of learning and innovation.
How to Apply
If you meet the eligibility criteria and are ready to embark on a career in pharmacovigilance, please submit your application through the official Parexel Careers portal. Ensure that your resume highlights your academic background and any relevant internship or project experience.
Click Here to Visit the Official Application Portal