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.

More Jobs at Thepharmadaily

Regulatory Affairs Specialist

Hyderabad, Telangana, India

4.0 - 7.0 yrs

INR 3 - 7 Lacs

PV Specialist

Noida, Uttar Pradesh, India

2.0 - 4.0 yrs

INR 3 - 7 Lacs

Project Specialist

Hyderabad, Telangana, India

1.0 - 3.0 yrs

INR 8 - 13 Lacs

Specialist, PV

Ahmedabad, Gujarat, India

2.0 - 4.0 yrs

INR 3 - 7 Lacs

Senior Statistical

Delhi, Delhi, India

6.0 - 9.0 yrs

INR 8 - 13 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.