Drug Safety Physician

1 month ago

Bengaluru, India Biocon Biologics Full time

We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information.

Responsibilities:

  • Contributes to the development & maintenance of product safety profile.
  • Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products
  • Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns.
  • Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients
  • Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation
  • Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders
  • Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis.
  • Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements.
  • Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information


  • Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc
  • Have thorough medical oversight over the external vendors on the medical review of ICSRs
  • Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
  • Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams
  • Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc
  • Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process
  • Provides inputs to various pharmacovigilance documents like PSMF, SDEA
  • Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance
  • 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
  • Participates and supports pharmacovigilance audit/inspection preparation and CAPA management
  • Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners.
  • Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance.
  • Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.
  • Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).
  • Trains and mentors the team members.

Other Drug Safety Physician responsibilities include:

  • Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
  • Includes knowledge of case processing, expedited reporting and safety database concepts
  • Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated
  • Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders
  • Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities
  • Strong organisational skills, including capability to prioritise independently with minimal supervision.

Qualifications

  • MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia
  • Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities.
  • High degree of professionalism, maturity, business understanding and passion.
  • Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
  • Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.
  • Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc)


Job Location:

Bangalore, India.

  • Drug safety physician

    1 month ago

    Bengaluru, India Biocon Biologics Full time

    We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...

  • Drug Safety Physician

    1 month ago

    Bengaluru, India Biocon Biologics Full time

    We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...

  • Sr Mgr PhV Safety Physician

    4 weeks ago

    Bengaluru, India Teva Pharmaceuticals Full time

    The opportunityThe Safety Physician leads the safety profile of specific medicinal products assigned to him/her throughout various stages in the product lifecycle. In partnership with other Teva stakeholders, the Safety Physician identifies and defines the risks of Teva's drugs and proposes measures to monitor, minimize, or mitigate them. The Safety...

  • Sr Mgr PhV Safety Physician

    4 weeks ago

    Bengaluru, India Teva Pharmaceuticals Full time

    The opportunityThe Safety Physician leads the safety profile of specific medicinal products assigned to him/her throughout various stages in the product lifecycle. In partnership with other Teva stakeholders, the Safety Physician identifies and defines the risks of Teva's drugs and proposes measures to monitor, minimize, or mitigate them. The Safety...

  • SERM Principal Physician

    3 months ago

    Bengaluru, India ScaleneWorks Full time

    Key Responsibilities: 1.Scientific/Medical Knowledge PV Expertise: • Responsible for signal detection and evaluation activities for assigned products. • Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data. • Assists in the...

  • Senior Drug Safety Technology Strategist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the RoleWe are seeking a Senior Drug Safety Technology Strategist to join our team at Lifelancer. As a key member of our organization, you will be responsible for delivering solutions in line with the Drug Safety roadmap with a focus on improving efficiency.ResponsibilitiesDevelop and implement technology strategies to support business objectives in...

  • Biocon Biologics Safety Expert Lead

    1 week ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    We are seeking an experienced Drug Safety Physician to join our Pharmacovigilance team at Biocon Biologics. This is a challenging opportunity for a highly skilled professional to lead the evaluation of safety profiles for our company products, drive risk management initiatives, and ensure compliance with global regulatory requirements.

  • Senior Drug Safety Systems Engineer

    1 week ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the Job">We are seeking an experienced Senior Drug Safety Systems Engineer to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT.Job Description">As a Senior Drug Safety Systems Engineer, you will be responsible for delivering solutions in line with the Drug Safety roadmap, focusing on improving efficiency...

  • Aggregate Report Physician

    6 months ago

    Bengaluru, Karnataka, India ClinChoice Full time

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Aggregate Report Physician to join one of our clients. **Main Job Tasks and Responsibilities**: - Aggregate Report...

  • Drug Safety Expert I

    6 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...

  • Literature Review Physician

    6 months ago

    Bengaluru, Karnataka, India ClinChoice Full time

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Literature Review Physician on a permanent basis. You will work on projects from our varied client base,...

  • Serm Principal Physician

    3 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    **Site Name**: Bengaluru Luxor North Tower **Posted Date**: Nov 26 2024 1.Scientific/Medical Knowledge PV Expertise - Responsible for signal detection and evaluation activities for assigned products. - Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests...

  • Clinical Research Physician Leadership Role in Drug Development

    1 week ago

    Bengaluru, Karnataka, India Lifelancer Full time

    Company Overview">Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. Our goal is to unite caring with discovery to make life better for people worldwide.We are a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving the understanding and management of...

  • Principal Consultant- Argus Drug Safety Migration expert

    6 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...

  • Drug Safety Surveillance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    Job OverviewThis role involves providing critical support to the Life Sciences RD vertical at Accenture, focusing on pharmacovigilance services. The successful candidate will be part of a team that helps biopharma companies bring their vision to life by converging scientific expertise with unique insights into patient experience.About the RoleIn this...

  • Senior Software Engineer

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects talent with opportunities.Job Title: Senior Software Engineer - Global Drug Safety Data PlatformsWe are seeking a highly skilled Senior Software Engineer to join our team in Bengaluru, India. This role will involve delivering solutions for Global Drug Safety...

  • Quality Assurance Analyst

    2 weeks ago

    Bengaluru, India Growel Softech Pvt. Ltd. Full time

    Payroll - QA Analyst Job Description : The candidate should be adaptive to a continuous changing and fast paced environment, be able to successfully multi-task, and thrive in a dynamic, fully engaged QA role. The role will involve interacting with clients in the Business, developers, external vendors, and other QA teams. Ready to attack any challenge,...

  • Junior Drug Safety Associate

    17 hours ago

    Bengaluru, Karnataka, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...

  • Critical Care Physician

    6 months ago

    Bengaluru, Karnataka, India sourcetrace consulting Full time

    Hi All, We are looking for Critical Care physician for our Healthcare client in bangalore. MBBS+ICU experience we need min 1yr PFB the JD: KEY RESPONSIBILITIES -CCA works closely with the intensivists in providing high quality critical care from our care center, based in Bangalore. -Accompany the intensivist in conducting tele rounds, which involve...

  • Safety Writer

    7 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...