Aggregate Report Writer (Medical Report Writer)
NOVUMGEN
- Location
- Vadodara, Gujarat, India
- Job type
- Full-time
Required skills
- clinical trials
- cross-functional
- data mining
- time management
About the role
NOVUMGEN
Website:
novumgen.com
Job details:
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
- Strong communication and presentation skills
- Advanced knowledge of MS Office
- Fluency in English
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