Safety Surveillance Advisor I

Clinicalresearchinfo

5 months ago

Location: Bangalore, Karnataka, IN

Act as Owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer.
As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs).
Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator’s Brochure (IB), integrated safety summaries, abstracts and planned publications.
You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required.
Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs).

Qualifications

Masters in Medicine/MD post MBBS graduate is Preferred.
Relevant Experience in Signal Management, Aggregate Management, ICSR.
Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint).
Fluent in written and spoken English.
Analytical mind-set.
Professional authority.
Quality mind-set, well-organised and strive for excellence.
Pro-active planner to meet agreed deliverables.
Strong communicator (verbally and in writing).
Curious and constantly looking for improvement opportunities.
Team player with high degree of flexibility and service mindedness.
Cross-cultural awareness.
Ability and willingness to quickly adjust to changes in a continuously developing environment.