Safety Surveillance

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
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.

  • Senior Medical Safety Advisor

    4 weeks ago

    Bengaluru, Karnataka, India IQVIA Full time

    Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same...

  • Director of Campus Safety

    1 day ago

    Bengaluru, Karnataka, India beBeeSecurity Full time ₹ 20,00,000 - ₹ 25,00,000

    Chief Security Officer - Leading Campus SafetyWe are seeking a highly skilled and experienced Chief Security Officer to oversee the overall security operations across our university campuses.This leadership role requires strong administrative skills, integrity, and the ability to operate in a dynamic university environment.Lead, plan, and coordinate all...

  • Drug Safety Physician

    3 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a...

  • Risk and Compliance

    3 weeks ago

    Bengaluru, Karnataka, India Thepharmadaily Full time

    Job DescriptionRoles & Responsibilities- Build knowledge and support the team.- Participate in problem-solving discussions.- Conduct risk assessments to identify potential compliance issues.- Ensure adherence to compliance standards and regulations.- Provide guidance and support on compliance-related matters.- Collaborate with cross-functional teams to...

  • Senior Manager, Physical Security and Safety

    3 days ago

    Bengaluru, Karnataka, India Pure Storage Full time US$ 1,00,000 - US$ 1,50,000 per year

    We're in an unbelievably exciting area of tech and are fundamentally reshaping the data storage industry. Here, you lead with innovative thinking, grow along with us, and join the smartest team in the industry.This type of work—work that changes the world—is what the tech industry was founded on. So, if you're ready to seize the endless opportunities and...

  • Safety Evaluation Scientist-Literature

    7 days ago

    Bengaluru, Karnataka, India GSK Full time US$ 90,000 - US$ 1,20,000 per year

    Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Relevant Years of experience 3 to 6 years.Perform PV literature surveillance assessment activities according to regulations and agreed processes.Timely production of key deliverables including but not limited to:- Screen and review literature search results...

  • Associate I

    1 week ago

    Bengaluru, Karnataka, India Alcon Full time US$ 90,000 - US$ 1,20,000 per year

    Duties are listed in order of greatest importance. Other responsibilities may be assigned. Act as the primary author for regulatory safety information required in technical files, including but not limited to post-market surveillance plans, safety narratives, and aggregate reports (e.g., periodic safety update reports) across regions. Address reviewers'...

  • Medical Reviewer-Drug Safety Physician

    5 days ago

    Bengaluru, Karnataka, India Indegene Full time

    We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation,...

  • Chief Security Officer

    2 weeks ago

    Bengaluru, Karnataka, India Dayananda Sagar University Full time

    Job DescriptionJob Title: Chief Security Officer (CSO)Location: Dayananda Sagar University, Bengaluru, KarnatakaDepartment: Administration & SecurityExperience: Minimum 15+ yearsBackground Preferred: Retired Officer from Paramilitary Forces (e.g., CRPF, BSF, ITBP, CISF, SSB, etc.)Position Summary:Dayananda Sagar University is seeking a dynamic and...

  • Chief Security Officer

    14 hours ago

    Bengaluru, Karnataka, India Dayananda Sagar University Full time

    Job Title: Chief Security Officer (CSO)Location: Dayananda Sagar University, Bengaluru, KarnatakaDepartment: Administration & SecurityExperience: Minimum 15+ yearsBackground Preferred: Retired Officer from Paramilitary Forces (e.g., CRPF, BSF, ITBP, CISF, SSB, etc.)Position Summary:Dayananda Sagar University is seeking a dynamic and disciplined Chief...