Aggregate Report Writer (Medical Report Writer)

NOVUMGEN · India

Job Title: Aggregate Report Writer (Medical Report Writer)

Location: Vadodara

Experience: 1 to 3 Years

Key Responsibility:

1. Preparation and review of different aggregate reports like PSUR/PBRER, RMP, PADER, Annual safety reports and other safety reports
2. Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.
3. Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.
4. Conduct routine and ad-hoc signal detection activities using statistical methods and data mining techniques.
5. Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.
6. Prepare query responses and provide to internal stakeholders and regulatory authorities as needed.
7. Develop and refine methodologies for signal detection and risk assessment.
8. Participate in audits and inspections related to signal detection processes.
9. Stay updated on the latest developments in pharmacovigilance and signal detection methodologies
10. 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
• Strong communication and presentation skills
• Advanced knowledge of MS Office
• Fluency in English