Skill required: Pharmacovigilance Operations - Safety Writing Designation: Pharmacovigilance Services Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 3 to 5 years About Accenture 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 784,000 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 www.accenture.com What would you do? • • Use scientific expertise to develop high-quality medical scientific content outlines and guide the team in content development for assigned modules projects in line with client expectations.
• • Collaborate with cross-functional teams to support the medical legal regulatory (MLR) review process, respond to MLR review committee queries, and implement required changes effectively. • Management of the Affiliate Mailbox reconciliation of reports per process and performance of all written follow up attempts to include both Serious and Non serious cases • Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed interim clinical study reports.
What are we looking for? • Primary skill - Safety Writing - P5 • • Bachelor s or masters degree in pharmacy life sciences. • • 1.5 - 3 years of experience in reviewing medical documents Medical referencing. • • Proficiency in medical referencing techniques and awareness of industry standards. • • Exhibit proficiency in MS Office applications, including Excel, Adobe Acrobat, Outlook, and PowerPoint.
• • Strong organizational skills and attention to detail. • • Effective interpersonal and communication skills. • • Ability to work well in a dynamic team environment. • • Experience with Veeva Vault PromoMats Vault ProMotion is preferr Roles and Responsibilities: • • Use scientific expertise to develop high-quality medical scientific content outlines and guide the team in content development for assigned modules projects in line with client expectations.
• • Collaborate with cross-functional teams to support the medical legal regulatory (MLR) review process, respond to MLR review committee queries, and implement required changes effectively. • • Experience in writing white papers, manuscripts, point of view, etc. • • Write scientific content for projects if the nature of the project is extremely complex and it requires expertise or based on business need.
• • Communicate the clinical data in a clear and concise manner. • • Follow department best practices for processes, communication, project management, documentation, and technical requirements. • • Converts relevant data and information into a form that meets regional regulatory requirements. • • Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs to comply with regulatory requirements.
• • Completes assignments independently or for more complex documents, under the guidance of a mentor. • • Ensure compliance with client and Accenture internal SOPs for all materials. • • Collaborate with technology and creative teams to develop innovative digital solutions. • • Ensure quality delivery and client engagement for organic growth Bachelor of Pharmacy About Accenture Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth a