Aggregate Report Writer PSUR & DSUR | WFH

2coms; Kuala Lumpur; Remote; MYR 40,000 - 60,000; Full time

Job summary

A leading company in the Pharma/Biotech sector is seeking an Aggregate Report Writer PSUR & DSUR to focus on safety and data analysis. The successful candidate will compile reports, analyze trends in safety data, and work collaboratively with colleagues to address safety issues. This remote role emphasizes strong communication and analytical skills, ensuring compliance with client training and quality standards.

Qualifications

• Experience in patient safety or related field required.
• Strong skills in communication and teamwork.
• Commitment to timely completion of tasks and documentation.

Responsibilities

• Compile PBRERs with a focus on medical aspects and safety.
• Analyze safety trends and source data.
• Collaborate with Therapeutic Head on product safety concerns.

Skills

Strong presentation and communication skills

Effective intercultural work capabilities

Analytical and problem-solving skills

Collaboration and teamwork abilities

Education

Relevant educational background in patient safety or related field

Job description

Aggregate Report Writer PSUR & DSUR || WFH

• Industry Pharma/Biotech/Clinical Research
• Country India
• Dial in Number [phone]
• Dial in Extension to connect with Recruiter 330
• Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries
  
• Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends
  
• Collaborating with Therapeutic Head to identify signals and address product safety concerns
  
• Engaging with Therapeutic Area colleagues for enhanced understanding and development
  

Measurable Goals

• Ensuring 100% compliance with timely completion of all client and Cognizant required trainings
  
• Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks
  

Non-Measurable Attributes

• Self-motivated
  
• Goal-oriented
  
• Personal grooming and etiquette
  
• Punctuality
  
• Team player and process-oriented
  
• Effective at collaborating across different cultures
  
• Strong preference for structured and process-driven tasks
  
• Committed to completing training and documentation on time
  

Experience

• Relevant educational background and experience in patient safety or related field
  

Required Skills

• Strong presentation and communication skills
  
• Effective intercultural work capabilities
  
• Commitment to timely completion of tasks and documentation
  
• Analytical and problem-solving skills
  
• Collaboration and teamwork abilities
  

Requirements

• Relevant educational background and experience in patient safety or related field
  
• Strong presentation and communication skills
  
• Effective intercultural work capabilities
  
• Commitment to timely completion of tasks and documentation