Latest Clinical Senior Analyst at Accenture for B pharm Candidates, Interested and eligible check out all the details given for the same below.
Job position: Health Clinical Service Senior Analyst
Job Location: Bengaluru
Skill required: Pharmacovigilance – Safety Writing
Designation: Senior Regulatory Services Scientist
Qualifications: Bachelor of Pharmacy
Years of Experience: 5 to 8 years
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.
What would you do..?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Support in the context of public disclosure of Clinical Study Reports (CSRs), associated statistical documents, synopsis, protocols, statistical analysis plans, and other clinical documents in accordance with client and Regulatory requirements as communicated by the client.
• Clinical documents should be redacted to protect the privacy of individuals, groups, and staff associated with a clinical study so that these documents can be made available for public, post approval from EU and US regulatory authorities.
• Privacy data should be removed or redacted from CSRs, associated statistical documents, synopsis, protocols, statistical analysis plans and other clinical documents before public disclosure per the Clinical Document Redaction Checklist.
• Quality review of redacted clinical documents per specific guidelines.
• Finalization of the fully redacted document Ensure to complete the task including redaction and incorporation of QC comments in CSRs, associated statistical documents, synopsis, protocols, statistical analysis plans, and other clinical documents within the agreed timelines.
• Provide trainings to new joiners and other team members as and when required.
• Must be well versed with EU Policy 70 and Health Canada guidelines on clinical data transparency.
• Working knowledge of patient safety narratives and other clinical documents like Clinical Study Report, Protocol and Investigator’s brochure would be useful.
What Are we looking for..?
• Ability to work well in a team
• Problem-solving skills
• Adaptable and flexible
• -Policy 70 and Health Canada data transparency guidelines.
• Patient Safety narratives
• Clinical documents like Clinical Study Report, Protocol, and Investigator’s brochure
Roles and Responsibilities For Clinical Senior Analyst at Accenture :
• In this role you are required to do analysis and solving of increasingly complex problems
• Your day to day interactions are with peers within Accenture
• You are likely to have some interaction with clients and/or Accenture management
• You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments
• Decisions that are made by you impact your own work and may impact the work of others
• In this role you would be an individual contributor and/or oversee a small work effort and/or team
• Please note that this role may require you to work in rotational shifts
Possible Interview Questions with Answers may be asked for Clinical Senior Analyst at Accenture
1. Can you explain your experience in pharmacovigilance safety writing and its importance in the pharmaceutical industry?
Answer: Certainly. I have over 5 years of experience in pharmacovigilance, specifically in safety writing. Safety writing is a critical aspect of the pharmaceutical industry as it involves the documentation and communication of safety-related information about drugs and medical products. This information is essential for regulatory compliance and ensuring patient safety. In my role, I have been responsible for preparing and reviewing various safety documents, including adverse event reports, safety narratives, and clinical study reports, to ensure accuracy and compliance with regulatory guidelines.
2. How do you ensure the privacy of individuals, groups, and staff associated with a clinical study when redacting clinical documents?
Answer: Protecting the privacy of individuals and staff involved in clinical studies is a top priority. To ensure privacy during the redaction process, I follow established guidelines and the Clinical Document Redaction Checklist. This involves removing or redacting any sensitive or personally identifiable information from clinical documents, such as names, addresses, and contact details. The goal is to make these documents suitable for public disclosure while safeguarding the privacy of those involved in the studies.
3. Can you provide an example of a challenging situation you encountered while redacting clinical documents and how you resolved it?
Answer: Certainly. In one instance, I came across a complex clinical document with extensive privacy-sensitive information. The challenge was to redact this information while maintaining the document’s overall coherence and readability. To address this, I developed a meticulous redaction plan, involving the use of specialized software for automated redaction and a manual review process. This combination ensured that sensitive data was effectively removed, and the document remained clear and comprehensible.
4. How do you stay updated with the evolving regulatory guidelines, such as EU Policy 70 and Health Canada guidelines, in the context of clinical data transparency?
Answer: Staying updated with evolving regulatory guidelines is essential in pharmacovigilance. I regularly monitor regulatory websites, attend industry conferences, and participate in training programs offered by reputable organizations. Additionally, I am part of professional networks where experts share insights and updates on regulatory changes. This proactive approach helps me stay informed about the latest guidelines, including EU Policy 70 and Health Canada guidelines, ensuring our practices remain compliant.
5. Can you describe your experience in providing training to new team members and colleagues?
Answer: Training is a crucial aspect of ensuring a cohesive and skilled team. In my previous roles, I have provided training to new team members and colleagues on various aspects of pharmacovigilance, safety writing, and compliance with regulatory requirements. This includes conducting training sessions, creating educational materials, and offering mentorship to help individuals understand the processes and best practices in our field.