NOVUMGEN, a leader in the pharmaceutical industry, is renowned for its commitment to innovation and compliance. Based in Vadodara, Gujarat, NOVUMGEN specializes in developing high-quality pharmaceutical products and ensuring their safety and efficacy through rigorous pharmacovigilance practices.
Job Overview
As an Aggregate Reporting Specialist in the Pharmacovigilance team, you will play a pivotal role in preparing and submitting comprehensive safety reports, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs). This position ensures compliance with global regulatory requirements and contributes to maintaining the safety profile of the company’s products.
Key Responsibilities
Report Preparation and Submission
- Compile, review, and submit aggregate safety reports (PSURs, DSURs, and others) in adherence to regulatory requirements.
- Collaborate with cross-functional teams to collect and analyze data from clinical trials, spontaneous reports, and literature.
Risk Assessment and Compliance
- Conduct detailed risk assessments and benefit-risk evaluations to support safety reporting.
- Ensure timely and accurate submissions to regulatory authorities and internal stakeholders.
- Stay informed of global regulatory standards, guidelines, and industry best practices related to aggregate reporting.
Audit and Process Improvement
- Participate in audits and inspections, ensuring compliance with regulatory standards.
- Assist in developing and updating standard operating procedures (SOPs) for aggregate reporting.
Safety Monitoring and Trends
- Monitor emerging safety issues and trends relevant to NOVUMGEN’s product portfolio.
- Utilize pharmacovigilance databases like ARGUS and VigiBase for safety data management.
Qualifications
Educational Background
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field is required.
- Advanced degrees (M.S., Ph.D.) are preferred.
Experience and Skills
- A minimum of 4 years of experience in pharmacovigilance or drug safety, focusing on aggregate reporting.
- In-depth knowledge of global regulatory requirements, including ICH, FDA, and EMA guidelines.
- Proficiency in pharmacovigilance databases (e.g., ARGUS, VigiBase).
- Strong data analysis and interpretation skills, with experience using statistical tools.
- Excellent written and verbal communication skills, coupled with strong organizational abilities.
