Job Title: Operation Specialist – Pharmacovigilance
Locations: Bangalore & Thane
About Maiora:
Join Maiora, a dynamic and growing organization, and advance your career in the critical field of Pharmacovigilance (PV). We are seeking a motivated and detail-oriented Operation Specialist to contribute to our global safety operations. This role offers hands-on experience in ICSR case processing, regulatory submissions, and safety database activities. If you have a solid foundation in PV and are looking for career stability, professional growth, and exposure to a global environment, we encourage you to apply.
Job Summary:
We are seeking an experienced Operation Specialist to join our Pharmacovigilance team. In this role, you will be responsible for processing Individual Case Safety Reports (ICSRs), managing regulatory submissions, and contributing to the maintenance of our safety databases. The ideal candidate will possess a strong understanding of global PV regulations, excellent analytical skills, and a commitment to maintaining high-quality standards.
Key Responsibilities:
As an Operation Specialist – Pharmacovigilance, your responsibilities will include:
- ICSR Case Processing: Process ICSR safety cases accurately and efficiently within safety databases, ensuring compliance with established timelines and quality standards.
- Regulatory Submissions: Manage and coordinate regulatory submission activities, ensuring timely and accurate submission of safety data to relevant authorities.
- Training and Compliance: Complete all assigned training modules within specified timelines to stay updated on current regulations and best practices. Adhere strictly to global regulations, guidelines, Standard Operating Procedures (SOPs), and project requirements in handling safety data.
- End-to-End Pharmacovigilance Activities: Perform comprehensive PV activities, including:
- Collecting and tracking Adverse Events (AEs) from various sources.
- Determining the initial and update case status based on information received.
- Coding AEs and products using appropriate coding dictionaries.
- Writing clear, concise, and high-quality narratives summarizing safety information.
- Performing literature surveillance to identify potential safety signals.
- Quality and Productivity: Maintain high levels of productivity and quality in all project tasks, ensuring accuracy and adherence to established standards.
- Project Support: Support compliance with project processes and documentation, ensuring all activities are conducted in accordance with project plans.
- Safety Case Management: Create and track safety cases according to project plans, ensuring timely and accurate documentation.
- Issue Identification: Identify potential quality issues and escalate them appropriately to ensure timely resolution.
- Mentoring: Mentor new team members as assigned, providing guidance and support to facilitate their integration into the team and projects.
- Meeting Participation: Actively participate in project meetings, providing actionable updates and contributing to discussions.
- Organizational Adherence: Ensure 100% adherence to organizational people practices, policies, and procedures.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related field.
- Minimum of 1.5 years of proven experience in Pharmacovigilance is mandatory.
- Experience in ICSR case processing, including coding, narrative writing, and literature review.
- In-depth knowledge of global PV regulations and guidelines (e.g., FDA, EMA).
- Excellent communication skills, both written and verbal.
- Strong analytical thinking and problem-solving abilities.
- Exceptional attention to detail and a commitment to accuracy.
Benefits of Joining Maiora:
- Global Projects: Opportunity to contribute to global PV projects, expanding your knowledge and experience in international regulations.
- Skill Development: Continuous training and development opportunities to enhance your skills and stay current with industry best practices.
- Career Growth: Mentorship programs and opportunities for career advancement within the organization.
- Competitive Compensation: Competitive salary and a performance-driven environment that recognizes and rewards your contributions.
- Team-Oriented Culture: On-site, team-oriented work culture that fosters collaboration and mutual support.
How to Apply:
If you meet the qualifications and are interested in this exciting opportunity, please submit your resume directly to [email protected]. Please include “Application for Operation Specialist – PV” in the subject line of your email. We look forward to hearing from you!