THThepharmadaily
Safety Surveillance
Bangalore ₹8-13 LPA Posted 13 Aug 2025
FULL TIME
Excel
And Powerpoint
Word
Outlook
Job Description
- Acting as the owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products.
- Maintaining labeling for marketed products and participating as a labeling change request (LCR) reviewer.
- Preparing 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).
- Providing safety input to Product Development Plans (PDP), Trial Outlines, Protocols, Clinical Trial Reports, Investigator s Brochures (IB), integrated safety summaries, abstracts, and planned publications.
- Proactively communicating safety issues through participation in project/trial groups/teams and conducting Investigator training.
- Responding to inquiries from Health Authorities (HAs) and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/Informed Consent (ICs).
- Establishing and ensuring deliverables to/from Data Monitoring Committees (DMCs).
- Qualifications:
- Masters in Medicine/MD post-MBBS graduate is preferred.
- Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSR).
- Proficient in Microsoft Office (Outlook, Word, Excel, and PowerPoint).
- Fluent in written and spoken English.
- Analytical mindset with a professional authority.
- Quality-oriented, well-organized, and striving for excellence.
- Proactive planner to meet agreed deliverables.
- Strong communicator (verbally and in writing).
- Curious and constantly looking for improvement opportunities.
- Team player with a high degree of flexibility and service-mindedness.
- Cross-cultural awareness.