Pharmacovigilance Associate

Why This Role Matters

Pharmacovigilance within a specialty pharmacy setting is essential to safeguarding patients who rely on high-risk, complex, or chronic therapies. Continuous monitoring of adverse events, drug interactions, and safety signals ensures compliance with regulatory requirements and strengthens patient trust.
This role plays a critical function in maintaining drug safety standards, enhancing reporting accuracy, and supporting quality improvement initiatives. By collaborating with clinical and compliance teams, the position contributes directly to patient well-being and regulatory excellence.

Job Description

The Pharmacovigilance Associate is responsible for overseeing drug safety monitoring, adverse event reporting, regulatory compliance, and quality assurance activities. The role involves collection and evaluation of safety data, preparation of regulatory submissions, and implementation of pharmacovigilance policies aligned with industry standards.
The position requires strong analytical skills, attention to detail, and the ability to work both independently and collaboratively in a fast-paced specialty pharmacy environment.

Key Features of the Role

• Direct involvement in adverse event monitoring and reporting
• Exposure to regulatory compliance and safety management processes
• Collaboration with clinical and compliance teams
• Participation in risk management and quality assurance activities
• Opportunity to contribute to SOP development and staff training
• Competitive compensation and career growth opportunities

Responsibilities

• Monitor, evaluate, and report adverse events and potential drug interactions as per regulatory requirements
• Collect, assess, and document pharmacovigilance data from patients, healthcare providers, and stakeholders
• Perform root cause analyses to identify safety issues and implement corrective actions
• Prepare and submit pharmacovigilance reports within regulatory timelines
• Collaborate with clinical and compliance teams for follow-up reporting and documentation
• Develop, update, and implement pharmacovigilance policies, SOPs, and protocols
• Conduct risk assessments and contribute to risk management planning
• Provide pharmacovigilance training and awareness sessions for staff
• Stay updated with regulatory changes and adapt safety processes accordingly
• Reconcile monthly safety reports to verify data accuracy and identify discrepancies
• Conduct audits and quality reviews of pharmacovigilance processes
• Perform additional drug safety responsibilities as assigned

Required Qualifications

• Strong understanding of pharmacovigilance regulations and safety reporting requirements
• Knowledge of pharmacological and medical terminology
• Proficiency in safety databases and reporting tools
• Strong analytical and organizational skills
• Excellent written and verbal communication abilities
• Commitment to patient safety and regulatory compliance

Educational Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare field preferred

Experience and Skills

• Minimum 2 years of experience in pharmacovigilance or drug safety (mandatory)
• Experience in specialty pharmacy or clinical setting preferred
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
• Experience handling safety databases and information management systems
• Ability to work independently and within cross-functional teams
• Strong attention to detail and documentation accuracy

Salary Insights

• Monthly salary range: ₹30,000 – ₹60,000
• Compensation depends on experience, regulatory exposure, and database expertise
• Candidates with strong safety reporting and audit experience may be positioned at the higher end of the salary range

Company Overview

Rx Connect Specialty Pharmacy is a leading specialty pharmacy dedicated to providing high-quality medications and patient support services for individuals with complex, chronic, and rare conditions. The organization focuses on patient safety, regulatory compliance, and excellence in pharmacy operations. With a commitment to continuous quality improvement, Rx Connect Specialty Pharmacy aims to enhance therapeutic outcomes while maintaining the highest safety standards.

FAQs

• Is pharmacovigilance experience mandatory?
Yes, a minimum of 2 years of relevant experience is required.

• Is this an on-site role?
Yes, the work location is in-person in Mohali, Punjab.

• Does the role involve regulatory reporting?
Yes, preparation and submission of safety reports is a key responsibility.

• Are there growth opportunities?
Yes, the company offers career advancement within its expanding operations.

Application Tips

• Highlight specific adverse event reporting experience
• Mention safety database expertise clearly
• Demonstrate experience in SOP development or audit participation
• Emphasize collaboration with clinical or compliance teams
• Showcase measurable contributions to patient safety or quality improvements