Pharmacovigilance - Safety Writing
Senior Regulatory Services Scientist
Bachelor of Pharmacy
Years of Experience:
7 to 11 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.Visit us at
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.
• Support for Clinical Submission Narrative Writing (Narrative Writing) for Phase 1-4 clinical trials in accordance with client SOP.
• Handle and manage the narrative studies as a Project Lead
• Working knowledge of other clinical documents like Clinical Study Report, Protocol and Investigator’s brochure would be useful.
What are we looking for?
• -- Select --
• Ability to establish strong client relationship
• Ability to manage multiple stakeholders
• Ability to meet deadlines
• Ability to perform under pressure
• -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
• In this role you are required to do analysis and solving of moderately complex problems
• May create new solutions, leveraging and, where needed, adapting existing methods and procedures
• The person would require understanding of the strategic direction set by senior management as it relates to team goals
• Primary upward interaction is with direct supervisor
• May interact with peers and/or management levels at a client and/or within Accenture
• Guidance would be provided when determining methods and procedures on new assignments
• Decisions made by you will often impact the team in which they reside
• Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
• Please note that this role may require you to work in rotational shifts