Drug Safety Associate - Aggregate Reporting

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: AR Specialist

Location: Mysore- Hybrid

Function: Drug Safety Services

The Aggregate Report Specialist creates and quality reviews documents pertaining to both pre‑marketing & post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These include but is not limited to integrated analyses of safety data in support of aggregate reports (e.g., Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Canadian Annual Reports, Development Safety Update Reports etc.), responses to regulatory queries on safety topics, post-marketing safety assessments.

The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Analyzes, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
  
• Authoring and review of Aggregate reports (PSURs/PBRERs/PADERs/Annual Reports/ ACO/ DSUR, health authority responses), RMP/REMS and signal management for submission to local and other Health Authorities
• Performing literature search and presentation of relevant articles for the aggregate reports.
  
• Management and reconciliation of relevant process trackers
  
• Subject matter expert (SME) along with training and mentoring of individuals
  
• Generation of Periodic Safety Line Listings (PSLL) from safety database
  
• Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
  
• Providing reliable support for high priority Ad-hoc activities
  
• Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients’ policies
  
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines
  
• Contributes to safety and pharmacovigilance training programs
  
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
  
• Attend internal and technical team meetings as required.
  
• Training and mentoring of Pharmacovigilance associates.
  
• Miscellaneous:
• Maintain rigorous adherence to written procedures, e.g., SOPs/Work instructions
  
• Adherence to Company Health & Safety procedures
  
• Participate in refresher training programmes.
  
• Should archive all documents internally as per procedure.
  
• Should complete all trainings on or before due date in relevant training platforms.
  
• Any other duties as assigned by your manager.

EDUCATION AND EXPERIENCE REQUIRED:

• Minimum 2 years of experience in authoring with at least 1 year of experience in Quality Review of Aggregate Reports


• 
  Degree in Life Science/Pharma or Equivalent

PREFERRED SKILLS:

• Preferred: 2 years of experience in authoring with 1 years of quality review of Aggregate Reports
  
• Knowledge of principles of epidemiology and statistics
  
• Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies.
  
• Good documentation practice
  
• Knowledge and information sharing
  
• Excellent attention to detail
  
• Proficient computer knowledge and computer keyboarding skills.
  
• Proficient with Microsoft Office Suite (Outlook, Word, Excel, PPT).
  
• Strong verbal, written and interpersonal communication skills.
  
• Flexibility to adapt and meet fluctuating business priorities.
  
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
  
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
  
• Innovative, collaborative, initiative-taker.
  
• Understanding of the principles of information storage and retrieval and skill in their application
  
• A solutions provider with strong multi-tasking abilities
  
• Manage evolving deadlines effectively with regular feedback and updates.