Work Location: Bangalore
Train and mentor the PV&DSS Support Specialists to provide a smoothly running department. Ensure that expeditable adverse events are processed to the required standard and submitted 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.
Responsibility to provide all clients, both internal and external with the appropriate quality of service in a safe and cost-effect 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:
- Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:
- maintenance of adverse event tracking systems
- set-up and maintenance of project files, core process files and central safety files
- reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.
- Provide administrative support to PV&DSS personnel (e.g. proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).
- Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA).
- Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
- Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA/Sr. DSA.
- Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
- Coordinate shipments of safety documents.
- Prepare and coordinate safety study files for archiving at completion of projects.
- Arrange and schedule internal and external meetings/teleconferences.
- Train and mentor the PV&DSS Support Specialists in their day-to-day activities.
- Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
- Build and maintain good PV&DSS relationships across functional units.
- 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