Work Location: Bangalore
Assist with the overall Clinical Safety and/or PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual
Essential Job Duties:
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against appropriate label
- identifies clinically significant information missing from initial reports and ensures its collection
- ensure case receives appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly.
- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
- Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.
- Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
- Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
- Work with Data Management or client on reconciliation of safety databases.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Build and maintain good PV&DSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
- Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Begin participating in Covance project teams and client meetings as appropriate.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Assist in the co-ordination of endpoint committees, as required.
- Any other duties as assigned by management
Top 3 reasons you should join us:
- Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
- Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.
- Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.
Get to know Covance
Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.
Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:
- LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”
- Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award
- IMDiversity – Corporate Diversity Honor Roll
- Flexjobs – Top 100 Remote Work – Company to Watch
- Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”
To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers