Skill required: Pharmacovigilance Operations - Safety Writing
Designation: Pharmacovigilance Services Associate
Qualifications:Master of Pharmacy
Years of Experience:1 to 3 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 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 www.accenture.com
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. 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. In this role, you will be expected to 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? •Ability to manage multiple stakeholders •Problem-solving skills •Results orientation •Written and verbal communication
Roles and Responsibilities: • Support for Clinical Submission Narrative Writing (Narrative Writing) for Phase 1-4 clinical Trials in accordance with client SOP. • Narratives are written based on data listings and/or safety reports (e.g., CIOMS). Safety reports will be provided to Vendor by client. • Provide 100% thorough check of all data points and in accordance with the client SOP and client Style Guide. • Provide finalized narrative which incorporates in-house client MD review comments as well as any Quality Control (QC) findings. • Provide Narrative Table of Contents for each project / study. • Handle and manage studies as a Project Lead