Pharmacovigilance Associate

Why This Role Matters
This role is critical for ensuring the safety of medicines and protecting patient health. As a Pharmacovigilance Associate, you will handle safety data, process Individual Case Safety Reports (ICSRs), and review literature to identify potential risks associated with pharmaceutical products. The work directly contributes to minimizing adverse effects and supporting global regulatory compliance. This position is ideal for professionals seeking to deepen their expertise in drug safety while working in a flexible, remote environment.

Job Description
Oviya MedSafe is seeking qualified Pharmacy or Life Sciences professionals to join its pharmacovigilance team. The role focuses on the accurate processing and documentation of safety data, literature screening, and case management in compliance with global regulatory guidelines. You will collaborate with cross-functional teams to maintain high-quality deliverables, support patient safety, and contribute to organizational excellence in drug safety operations.

Key Features of the Role:
• Processing of Individual Case Safety Reports (ICSRs)
• Conducting systematic literature review and safety data screening
• Ensuring compliance with global pharmacovigilance guidelines
• Accurate data entry and meticulous case documentation
• Collaborating with cross-functional teams for case resolution
• Maintaining timelines and quality standards for deliverables
• Assisting in preparation of reports for internal and external stakeholders

Responsibilities:
• Handle ICSRs from intake to submission, following standard operating procedures
• Conduct literature searches and reviews to identify safety signals
• Maintain accurate and complete case documentation
• Ensure compliance with ICH, CIOMS, and GVP guidelines
• Collaborate with medical, clinical, and regulatory teams to resolve case queries
• Track trends in safety data and escalate relevant findings
• Participate in audits or inspections when required
• Contribute to continuous improvement initiatives in pharmacovigilance processes

Required Qualifications:
• Educational qualification in Pharmacy or Life Sciences (B.Pharm, M.Pharm, Pharm.D, or equivalent)
• Hands-on experience in pharmacovigilance operations
• Exposure to ICSR processing, literature review, and drug safety activities
• Strong analytical skills and attention to detail
• Excellent written and verbal communication skills
• Ability to work independently in a remote setup and collaborate with teams

Educational Requirements:
• Bachelor’s or Master’s degree in Pharmacy, Pharm.D, or Life Sciences
• Registration with relevant professional bodies (if applicable) is preferred

Experience and Skills:
• 1–3 years of practical experience in pharmacovigilance operations
• Knowledge of global PV guidelines, compliance standards, and reporting processes
• Proficiency with safety databases, case management tools, and Microsoft Office Suite
• Strong interpersonal skills and teamwork orientation
• Problem-solving mindset with the ability to prioritize tasks effectively

Salary Insights:
• Estimated salary: ₹3,00,000 – ₹6,00,000 per annum, depending on experience
• Flexible remote working environment
• Opportunities for professional growth and career advancement in drug safety
• Supportive and inclusive work culture

Company Overview:
Oviya MedSafe is a leading pharmacovigilance services provider, supporting pharmaceutical companies globally in ensuring patient safety. The company emphasizes regulatory compliance, quality, and continuous professional development. Oviya MedSafe fosters a collaborative, innovative, and inclusive work environment, enabling employees to advance their careers in drug safety while contributing to better healthcare outcomes worldwide.

FAQs:
• Q: Is this role fully remote?
A: Yes, with occasional office visits if required.
• Q: What is the preferred location?
A: Candidates based in or near Coimbatore are preferred, but applicants from across India are welcome.
• Q: Are there growth opportunities?
A: Yes, the company encourages career progression within the pharmacovigilance domain.
• Q: Are there flexible working hours?
A: Yes, remote work provides flexibility while maintaining deliverable timelines.

Application Tips:
• Highlight hands-on experience with ICSRs and literature review
• Showcase knowledge of global pharmacovigilance guidelines
• Demonstrate attention to detail and ability to work independently
• Emphasize teamwork, communication skills, and commitment to patient safety
• Ensure all information provided is accurate for background verification