Current jobs related to Drug Safety Specialist Surveillance - Bengaluru - Biocon Biologics

  • Safety Surveillance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Safety Surveillance Specialist to join our Global Safety team at Novo Nordisk. As a key member of our team, you will be responsible for establishing and maintaining the product safety profile during development and maintenance of labelling for marketed products.Key ResponsibilitiesPerform ongoing and systematic...

  • Safety Surveillance Specialist

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Safety Surveillance Adviser to join our team at Novo Nordisk. As a Safety Surveillance Adviser, you will be responsible for establishing the product safety profile during development and maintenance of the labelling for marketed products. You will also perform ongoing and systematic surveillance of Novo Nordisk...

  • Safety Surveillance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Safety Surveillance Adviser to join our Global Safety - Global Business Services (GS-GBS) team at Novo Nordisk A/S. As a key member of our team, you will be responsible for establishing and maintaining the product safety profile during development and post-approval phases.Key ResponsibilitiesEstablish and...

  • Drug Safety Specialist

    2 weeks ago

    Bengaluru, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Job Description: - • The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). ...

  • Safety Surveillance Advisor

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Safety Surveillance Adviser to join our Global Safety team at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring the safety of our products throughout their lifecycle.Key ResponsibilitiesEstablish and maintain the product safety profile during development and maintenance of...

  • Safety Surveillance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Safety Surveillance Adviser to join our Global Safety - Global Business Services (GS-GBS) team at Novo Nordisk. As a key member of our team, you will be responsible for establishing and maintaining the product safety profile during development and maintenance of labelling for marketed products.Key...

  • Drug Safety Expert I

    4 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Drug Safety Expert I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety GBS (GS - GBS).- **The Position** - A Drug Safety Expert will be responsible to ensure all the conventions are followed by safety case handlers and would drive quality deliverables, he or she would act as a bridge...

  • Safety Surveillance Adviser I

    5 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Safety Surveillance Adviser I to join our team at Novo Nordisk. As a key member of our Global Safety - Global Business Services (GS-GBS) department, you will be responsible for establishing the product safety profile during development and maintenance of labelling for marketed products.Key ResponsibilitiesPerform...

  • Safety Surveillance Adviser I

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Safety Surveillance Adviser to join our team at Novo Nordisk. As a key member of our Global Safety - Global Business Services (GS-GBS) team, you will be responsible for establishing and maintaining the product safety profile during development and maintenance of labelling for marketed products.Key...

  • Safety Surveillance Adviser I

    2 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Safety Surveillance Adviser I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN **Department** : Global Safety - Global Business Services (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...

  • Safety Surveillance Adviser I

    2 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Safety Surveillance Adviser I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN **Department** : Global Safety - Global Business Services (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...

  • Safety Surveillance Advisor I

    5 months ago

    Bengaluru, India Novo Nordisk AS Full time

    Department  : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...

  • Safety Writer

    5 months ago

    Bengaluru, India Elixir Consulting Full time

    Location - Bangalore- Industry - Other- Contract Type - Permanent- Salary - ₹ 11,000,000- Published - 5 days ago - Contact - Reference - 29-25-10137- Academic title - Bachelor of ScienceJob description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and...

  • Safety Surveillance Adviser I

    2 months ago

    Bengaluru, India Novo Nordisk Full time

       Department : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...

  • Surveillance Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    About the RoleF335 Deutsche India Private Limited, Bangalore Branch is seeking a Surveillance Compliance Specialist to join our team in Birmingham, UK. As a Surveillance Compliance Specialist, you will be part of a team that performs surveillance tasks related to the Bank's Europe, Middle East & African operations.Key ResponsibilitiesParticipate in...

  • Risk Surveillance Specialist

    1 day ago

    Bengaluru, Karnataka, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    About the RoleWe are seeking a skilled Risk Surveillance Specialist to join our team at F335 Deutsche India Private Limited, Bangalore Branch. The successful candidate will be responsible for performing the review and investigation of surveillance alerts and escalations in a timely manner, taking any necessary action for Trading, Communications and...

  • Senior Financial Crime Surveillance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India HSBC Full time

    Transform Your Career with HSBCHSBC is a global banking and financial services organization with operations in 62 countries and territories. We're seeking an experienced professional to join our team in the role of Senior Financial Crime Surveillance Specialist.Key Responsibilities:Manage time-sensitive Financial Crime Surveillance issues arising from...

  • Principal Consultant- Argus Drug Safety Migration expert

    5 months ago

    Bengaluru, India Oracle Full time

    Job Description `Overview of the Organization Oracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national...

  • Clinical Surveillance Scientist

    4 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Surveillance Analyst Compliance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    About the RoleF335 Deutsche India Private Limited, Bangalore Branch is seeking a highly skilled Surveillance Analyst Compliance to join our team in Birmingham, UK. As a key member of our compliance surveillance team, you will be responsible for performing the review and investigation of surveillance alerts and escalations in a timely manner, taking any...

Drug Safety Specialist Surveillance

4 months ago

Bengaluru, India Biocon Biologics Full time

Job Description


The Idea candidate for the Drug Safety Specialist - Safety Surveillance and Risk Management Role's responsibility is as follows :


  1. Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Data from multiple sources are evaluated and authors the signal evaluation report and manages literature review for safety information.
  2. Prepares and maintains the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) including the risk minimization measures and is responsible for the monitoring of the effectiveness of risk minimization measures.
  3. Supports the process for responding to safety questions from regulatory authorities and partners in collaboration with service providers and crossfunctional teams
  4. Collaborates with aggregate report vendors having thorough oversight over scheduling, tracking, compliance and quality.
  5. Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions
  6. Supports the review and provides inputs to the safety sections of CCDS, local labels, health hazard analysis, QA trend analysis, device hazard lists etc
  7. Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).
  8. Participates and supports pharmacovigilance audit/inspection preparation and CAPA management.
  9. Prepares SOPs, working guidance and ensuring pharmacovigilance compliance.
  10. Follows document management as per good documentation practices and SOPs.
  11. Oversees and mentors Drug Safety Specialist
  12. Ensures compliance, reconciliation, and review of safety data exchange agreement between partners.
  13. Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.
  14. Collaborates well with drug safety physician and cross-functional teams (medical leads, clinical operations) for assigned clinical studies including SMP preparation/review, protocol review, IB review, SAE/SUSAR review, review of safety sections of DSUR, ASR, CSR etc
  15. Understands, interprets, analyse and clearly presents scientific and medical data in verbal and written format.
  16. Includes knowledge of case processing, expedited reporting and safety database concepts
  17. Demonstrates leadership and interacts collaboratively and effectively in a team environment (including safety, clinical development, medical affairs, regulatory, commercial, and devices) as well as with external colleagues.
  18. Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities
  19. Strong organizational skills, including the capability to prioritize independently with minimal supervision.