Job Title: Aggregate Report Writer (Medical Report Writer)
Location: Vadodara
Experience: 1 to 3 Years

Key Responsibility:

Preparation and review of different

aggregate reports like PSUR/PBRER, RMP, PADER,

Annual safety reports and other safety reports
Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.
Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.
Conduct routine and

ad-hoc signal detection activities

using statistical methods and data mining techniques.
Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.
Prepare query responses and provide to internal stakeholders and regulatory authorities as needed.
Develop and refine methodologies for

signal detection and risk assessment.




Participate in audits and inspections related to

signal detection processes.
Stay updated on the latest developments in pharmacovigilance and signal detection methodologies
Perform Ad-hoc activity reports as requested by health authorities.

Qualifications:

Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicines.
Previous 1-3 years’ experience of drug safety medical writing, including PBRERs, DSURs, RMPs and other aggregate reports
Time management, organisation and multitasking skills with good attention to detail
Robust communication and presentation skills
Advanced knowledge of MS Office
Fluency in English

📌 Aggregate Report Writer (Mumbai)
🏢 Novumgen
📍 Mumbai