NOVUMGEN has announced an opening for an Aggregate Report Writer (Medical Report Writer) in Vadodara, Gujarat. This opportunity is suitable for life sciences and healthcare professionals with experience in pharmacovigilance, drug safety medical writing, aggregate safety reports, and signal detection.

The selected candidate will work on important pharmacovigilance deliverables including PSUR/PBRER, RMP, PADER, DSUR, annual safety reports and other aggregate reports. The role also involves safety data analysis, signal detection, risk assessment and regulatory authority responses.

Candidates with a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biology, Chemistry, Veterinary Medicine or other relevant healthcare disciplines can consider this opportunity.

NOVUMGEN Aggregate Report Writer Job Overview

*Salary is an estimated market range for similar roles and is not disclosed in the provided NOVUMGEN job posting. Actual compensation may vary based on experience, skills and company policy.

About the Aggregate Report Writer Role

The Aggregate Report Writer at NOVUMGEN will support pharmacovigilance and drug safety activities by preparing, reviewing and maintaining aggregate safety reports.

The position requires experience with regulatory safety documents such as PBRERs, PSURs, DSURs, RMPs and PADERs, along with an understanding of signal detection and risk assessment processes.

Professionals interested in developing their careers in pharmacovigilance medical writing and aggregate reporting may find this role particularly relevant.

Key Responsibilities

• Prepare and review aggregate safety reports, including PSUR/PBRER, RMP, PADER and annual safety reports.
• Support preparation of other pharmacovigilance and regulatory safety reports.
• Analyze safety information collected from clinical trials, post-marketing sources and scientific literature.
• Work with cross-functional teams to evaluate and interpret drug safety data.
• Support preparation of signal detection reports.
• Conduct routine and ad-hoc signal detection activities using appropriate methodologies and data analysis techniques.
• Maintain awareness of applicable pharmacovigilance regulations, regulatory requirements and industry standards.
• Prepare responses to safety-related queries from internal stakeholders and regulatory authorities.
• Contribute to the development and refinement of methodologies used for signal detection and risk assessment.
• Participate in audits and inspections associated with pharmacovigilance and signal detection processes.
• Remain updated on developments in drug safety, aggregate reporting and pharmacovigilance signal detection.
• Prepare ad-hoc safety reports requested by health authorities.

Qualifications

Candidates should have a Bachelor’s or Master’s degree in Life Sciences or Healthcare.

Relevant qualifications may include:

B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, B.Sc Biology, M.Sc Biology, B.Sc Chemistry, M.Sc Chemistry, Veterinary Medicine and other relevant healthcare or life sciences qualifications.

Applicants should also have:

• Around 1–3 years of experience in drug safety or pharmacovigilance medical writing.
• Previous exposure to PBRER, PSUR, DSUR, RMP and other aggregate safety reports.
• Understanding of pharmacovigilance and drug safety processes.
• Strong time-management and organizational abilities.
• Ability to manage multiple assignments simultaneously.
• Strong attention to detail.
• Effective written and verbal communication skills.
• Good presentation skills.
• Advanced knowledge of Microsoft Office.
• Fluency in English.

Key Skills for This Role

Candidates with experience or knowledge in the following areas may be particularly relevant:

Pharmacovigilance | Aggregate Reporting | Medical Writing | Drug Safety | PSUR | PBRER | DSUR | RMP | PADER | Signal Detection | Risk Management | Safety Data Analysis | Regulatory Reporting | Literature Safety Data | Risk Assessment

Why Consider This Opportunity?

This Aggregate Report Writer job in Vadodara provides professionals with an opportunity to strengthen their expertise across multiple areas of pharmacovigilance.

The role offers exposure to:

• Global aggregate safety reporting
• Pharmacovigilance medical writing
• Signal detection activities
• Risk assessment
• Regulatory safety requirements
• Clinical and post-marketing safety data
• Cross-functional collaboration
• Regulatory authority queries
• Pharmacovigilance audits and inspections

Experience with PBRER, PSUR, DSUR and RMP preparation can also support long-term career development in aggregate reporting, signal management, risk management and broader pharmacovigilance functions.

How to Apply

Application Link