Job Title: Aggregate Report Writer (Medical Report Writer)

Location: VadodaraExperience: 1 to 3 Years

Key Responsibility:

Preparation and review of different

aggregate reports like PSUR/PBRER, RMP, PADER,

Annual safety reports and other safety reportsAnalyze 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 methodologiesPerform 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 reportsTime management, organisation and multitasking skills with positive attention to detailStrong communication and presentation skillsAdvanced knowledge of MS OfficeFluency in English

📌 Aggregate Report Writer (Medical Report Writer) (Mumbai)
🏢 Novumgen
📍 Mumbai