Medical Writer Executive (Aggregate Report Writing)

Role & responsibilities

• 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.

Preferred candidate profile

• Previous 2-5 years' experience of drug safety medical writing, including PBRERs, DSURs
• Strong communication and presentation skill.
• Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry,veterinary medicine)