592 Post Marketing Surveillance jobs in India

Clinical Research Associate

Mumbai, Maharashtra Bristol Myers Squibb

Posted 1 day ago

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Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Job Title/Role : Clinical Research Associate**
Position Summary: The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.
**Duties/Responsibilities:**
+ Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
+ Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
+ Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.
+ Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.
+ Motivate and influence sites to meet study objectives, including enrollment and retention goals.
+ Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
+ Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
+ Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
+ Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
+ Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
+ Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
+ Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
+ Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
+ Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
+ May support Ethics Committee submissions, ICF reviews, collection of documents to/from site
+ Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.
+ Support coordination of site activities related to database locks to ensure timelines are met as required locally.
+ Perform timely site closure activities when all required protocol visits and follow-up are completed.
**Qualifications:**
+ Bachelor's degree required, preferably within life sciences or equivalent
+ Valid driver's license (as locally required)
**Experience:**
+ Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role.
+ Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
+ Experience in the drug discovery/development process.
**Competencies:**
+ Knowledge and understanding of clinical research processes, regulations and methodology
+ Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
+ Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities ( Analytical thinking/critical thinking skills. Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions ( Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment
+ Organization and time management skills
+ Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders
+ Good verbal and written communication skills (both in English and local language)
+ Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.)
+ Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning
+ Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
+ Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity
**Software that must be used independently and without assistance:**
+ Microsoft Suite
+ Clinical Trial Management Systems (CTMS)
+ Electronic Data Capture Systems (eDC)
+ Electronic Trial Master File (eTMF)
+ RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :19:49.756 UTC
**Location:** Mumbai-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Clinical Research Associate

Sun Pharmaceuticals, Inc

Posted 4 days ago

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Job Description

**Job location:** Chennai
**YOUR TASKS AND RESPONSIBILITIES:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**WHO YOU ARE:**
+ Minimum qualification requirement is to have a Bachelor's or Masters degree in a health(1)related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
+ Relevant experience of 1-5 years minimum in the field of Clinical Research
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Clinical Research Coordinator

ClinoGenesis Research Institute

Posted 1 day ago

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Job Description

Clinical Research Coordinator (Freshers Only)


Location: (Insert City / Across India – Hybrid/On-site)

Organization: Clinogenesis Research Organization

Department: Clinical Operations

Employment Type: Full-Time


About Clinogenesis


Clinogenesis Research Organization is a growing, innovation-driven CRO committed to excellence in clinical research and data-driven healthcare. We provide aspiring professionals with a strong foundation to build rewarding careers in the clinical research field.


About the Role


We are inviting fresh graduates who are passionate about clinical research to join us as Clinical Research Coordinators This entry-level position offers hands-on exposure to clinical trial operations under the mentorship of experienced professionals.


Key Responsibilities


  • Support the coordination and execution of clinical trial activities at the site level.
  • Assist investigators in ensuring protocol adherence and accurate patient data documentation.
  • Maintain and update essential study documents, logs, and case report forms.
  • Ensure all research activities comply with **ICH-GCP**, regulatory, and ethical standards.
  • Participate in ongoing training, team discussions, and performance reviews to enhance learning.


Eligibility Criteria


  • Education: B.Pharm, M.Pharm, B.Sc / M.Sc in Life Sciences, Pharmacy, Nursing, or any equivalent healthcare discipline.
  • Experience: Freshers only (candidates with prior experience will not be considered).
  • Strong communication, interpersonal, and organizational abilities.
  • A keen interest in building a career in the clinical research domain.


Why Join Clinogenesis?


Learn directly from experienced mentors and clinical research experts.

Gain practical exposure in a globally recognized research environment.

Continuous learning and structured professional development programs.

Clear growth pathways and opportunities for long-term career advancement.





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Clinical Research Associate

Bengaluru, Karnataka LLRI - Learning Labb Research Institute

Posted 1 day ago

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Job Description

We are seeking a motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. As a Clinical Research Coordinator, you will play a crucial role in the planning, implementation, and coordination of clinical research studies. You will work closely with principal investigators, study participants, and other healthcare professionals to ensure the successful execution of research protocols in accordance with regulatory requirements and ethical standards.


Responsibilities:

  1. Coordinate and manage all aspects of clinical research studies from initiation to closeout.
  2. Screen, recruit, and enroll eligible participants according to study protocols.
  3. Obtain informed consent and ensure compliance with regulatory guidelines and institutional policies.
  4. Schedule study visits, perform study assessments, and collect study data accurately and in a timely manner.
  5. Communicate effectively with study participants, principal investigators, study sponsors, and other study team members.


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Clinical Research Coordinator

Bengaluru, Karnataka ClinoGenesis Research Institute

Posted 2 days ago

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Job Description


Clinical Research Coordinator (Freshers Only)

 Location: Hybrid/work from home

 Organization: Clinogenesis Research Organization

 Department: Clinical Operations

 Employment Type: Full-Time


About US

Clinogenesis Research Organization is a leading contract research organization committed to advancing clinical excellence and innovation. We partner with global clients to deliver high-quality, compliant, and ethically sound clinical research solutions. At Clinogenesis, we believe in nurturing new talent and providing a structured pathway for growth in the clinical research industry.


Position Overview

We are seeking motivated and detail-oriented Clinical Research Coordinators to join our Clinical Operations team. This entry-level position is designed for fresh graduates who wish to build a professional career in clinical research. The selected candidates will gain hands-on exposure to the execution and coordination of clinical trials in compliance with regulatory and ethical standards.


Key Responsibilities

  • Assist in the coordination and conduct of clinical trials under supervision.
  • Support investigators and site teams in maintaining protocol compliance and accurate data capture.
  • Maintain essential trial documentation, logs, and case report forms in accordance with GCP and SOP requirements.
  • Ensure adherence to ICH-GCP guidelines, applicable regulations, and ethical standards.
  • Participate in organizational training, meetings, and performance reviews to enhance professional competence.

Eligibility Criteria

  • Education: B.Pharm, M.Pharm, B.Sc / M.Sc in Life Sciences, Pharmacy, Nursing, or related healthcare disciplines.
  • Experience: Freshers only (candidates with prior industry experience will not be considered).
  • Strong communication, documentation, and organizational skills.
  • High level of integrity, attention to detail, and eagerness to learn.

What We Offer

  • Structured onboarding and mentorship under industry experts.
  • Exposure to global clinical operations and regulatory practices.
  • Continuous professional training and growth opportunities.

Apply now or send your resume to

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Clinical Research Coordinator

Delhi, Delhi MS CLINICAL RESEARCH

Posted 7 days ago

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Job Description

About the Job

We are looking for passionate Clinical Research Coordinators (CRC) to join our growing team. This is an exciting opportunity for fresh graduates with a clinical research course or background in life sciences/pharmacy who want to build a career in clinical trials and research.


Position Details

Role: Clinical Research Coordinator

Location: Delhi

Employment Type : Full-time

Experience: Freshers with clinical research training or related background encouraged to apply!


Key Responsibilities

  • Conduct clinical trials in compliance with ICH GCP and protocol guidelines.
  • Support study start-up activities and assist with site initiation.
  • Participate in recruitment and retention of study subjects.
  • Complete and maintain source documents, CRFs, and logs accurately.
  • Compile and update the Site Master File.
  • Manage Investigational Products (IP), including accountability and shipping.
  • Coordinate submissions and communication with the Ethics Committee.
  • Update sponsors on study progress and prepare for monitoring visits.
  • Perform other responsibilities assigned by management.


Who Can Apply

  • Freshers with a completed Clinical Research course.
  • Graduates/postgraduates in Life Sciences, Pharmacy, Biotechnology, or related fields.
  • Strong interest in clinical trials and regulatory compliance.
  • Excellent organisational, communication, and documentation skills.


Why Join Us?

Gain hands-on experience in clinical trials.

Learn directly from experienced professionals.

Be part of innovative projects that shape the future of healthcare.

A great opportunity to grow your career in clinical research.

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Clinical Research Associate

695001 Thiruvananthapuram, Kerala ₹850000 Annually WhatJobs

Posted today

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full-time
Our client is seeking a meticulous and dedicated Clinical Research Associate (CRA) to join our globally distributed, fully remote clinical operations team. This vital role is responsible for overseeing and managing clinical trials to ensure they are conducted, recorded, and reported in accordance with protocol, standard operating procedures, and regulatory requirements. You will be instrumental in monitoring study sites, ensuring data accuracy, and facilitating communication between the study team, investigators, and regulatory authorities. The ideal candidate will possess a strong background in clinical research, a deep understanding of Good Clinical Practice (GCP) guidelines, and excellent organizational and analytical skills. Experience with various therapeutic areas is a significant advantage. This is a remote-first position, requiring you to conduct site visits (as needed), manage remote data review, and maintain effective communication with teams and stakeholders across different locations. We are looking for individuals with a passion for advancing medical science and a commitment to patient safety. Responsibilities include site selection, initiation, monitoring, and close-out activities. You will also be responsible for ensuring regulatory compliance and timely reporting of study progress and adverse events. Our client is committed to fostering a supportive and collaborative remote work culture, offering significant opportunities for professional development and career advancement. Join us to contribute to groundbreaking pharmaceutical research and development from the convenience of your remote workspace. Your expertise will be crucial in bringing life-changing treatments to patients.
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Clinical Research Associate

700001 Kolkata, West Bengal ₹800000 Annually WhatJobs

Posted 1 day ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a meticulous and dedicated Clinical Research Associate (CRA) to join their team in **Kolkata, West Bengal**. This role offers a hybrid work model, combining office-based responsibilities with remote flexibility. The CRA will play a vital role in ensuring the successful execution of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.

Key responsibilities include initiating, monitoring, and closing out clinical trial sites. You will be responsible for conducting site visits, reviewing source documents, and ensuring that study protocols are followed accurately. The CRA will serve as the primary point of contact between the study sites and the sponsor, addressing any issues or concerns that may arise. You will also be involved in training site personnel on study procedures and requirements. The ideal candidate will possess strong knowledge of clinical trial processes, regulatory requirements, and data management. Excellent organizational, communication, and interpersonal skills are essential. You should be adept at problem-solving and possess a keen eye for detail to ensure data integrity and patient safety. The ability to travel to study sites is a requirement for this hybrid role.

Responsibilities:
  • Conduct pre-study, initiation, interim, and close-out visits for clinical trial sites.
  • Monitor clinical trial sites to ensure adherence to protocols, SOPs, and regulatory requirements (GCP).
  • Verify the accuracy, completeness, and validity of clinical trial data.
  • Review source documents and compare them with case report forms (CRFs).
  • Train site personnel on study-specific procedures and regulatory compliance.
  • Act as a liaison between the study sites and the sponsor organization.
  • Identify, document, and resolve study-related issues and deviations.
  • Ensure timely submission of all required study documentation.
  • Report on site performance and escalate issues as necessary.
  • Contribute to the development and maintenance of study protocols and other relevant documents.
Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role.
  • In-depth knowledge of clinical trial processes, GCP, and regulatory guidelines.
  • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Strong understanding of medical terminology and disease states.
  • Excellent organizational, time management, and problem-solving skills.
  • Exceptional written and verbal communication skills.
  • Ability to travel to clinical trial sites as required.
  • Detail-oriented and able to maintain high standards of accuracy.
This is a key opportunity for a seasoned CRA to contribute to groundbreaking pharmaceutical research while enjoying a flexible hybrid work arrangement.
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Clinical Research Associate

122001 Gurgaon, Haryana ₹650000 Annually WhatJobs

Posted 2 days ago

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full-time
Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate to join their team in **Gurugram, Haryana, IN**. This critical role involves overseeing and managing clinical trials to ensure data accuracy, patient safety, and adherence to regulatory guidelines. You will be responsible for site selection and initiation, monitoring study progress, and ensuring compliance with protocols and Good Clinical Practice (GCP) standards. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory requirements, and medical terminology. Excellent organizational, communication, and interpersonal skills are essential for effective site management and data collection. Responsibilities include conducting routine site visits, resolving issues at study sites, verifying source documentation against case report forms, and ensuring timely data entry. You will also be responsible for managing study supplies and ensuring the ethical conduct of research. This is an on-site position requiring regular travel to clinical trial sites. We are looking for a proactive individual with a keen eye for detail and a commitment to scientific integrity. The ability to manage multiple studies simultaneously and maintain strong relationships with investigators and site staff is crucial. This is an exciting opportunity to contribute to the development of life-saving therapies and advance your career in pharmaceutical research within a reputable organization. You will play a vital role in bringing innovative treatments from development to market, ensuring the highest standards of safety and efficacy are met throughout the clinical trial process.
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Clinical Research Associate

201301 Ghaziabad, Uttar Pradesh ₹70000 Annually WhatJobs

Posted 3 days ago

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full-time
Our client, a leading pharmaceutical organization, is seeking an experienced and dedicated Clinical Research Associate (CRA) to join their globally distributed team. This is a fully remote position, offering the flexibility to work from anywhere. As a CRA, you will play a vital role in ensuring the successful execution of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with regulatory standards and protocols. You will be responsible for managing multiple sites, building strong relationships with investigators and site staff, and contributing to the advancement of life-saving therapies. This role demands a high level of professionalism, meticulous attention to detail, and a strong understanding of clinical research principles.

Key Responsibilities:
  • Conduct pre-study, initiation, routine monitoring, and close-out visits to assigned clinical sites.
  • Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
  • Ensure adherence to the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulations.
  • Identify, evaluate, and select potential clinical investigators and sites.
  • Train and provide ongoing support to site staff regarding study procedures and requirements.
  • Manage communication between study sites, the sponsor, and other relevant parties.
  • Resolve site-level issues and escalate critical matters to the project manager as needed.
  • Ensure timely submission of all required regulatory and ethical documentation from sites.
  • Oversee subject recruitment and retention efforts at assigned sites.
  • Prepare monitoring visit reports and follow up on action items.
  • Maintain accurate and up-to-date site files and study documentation.
  • Contribute to the development and review of study-related documents, such as protocols and case report forms.
  • Ensure the safety and well-being of study participants.
  • Manage study timelines and deliverables for assigned sites.
  • Stay abreast of current trends and developments in clinical research and pharmaceutical development.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related discipline. Advanced degree preferred.
  • Minimum of 2-3 years of experience as a Clinical Research Associate.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
  • Proven experience in site monitoring and data verification.
  • Excellent understanding of clinical trial processes and drug development.
  • Strong organizational and time management skills.
  • Exceptional written and verbal communication abilities.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work independently and remotely, with a high degree of self-discipline and accountability.
  • Willingness to travel to sites as required (if applicable, but this role is remote-first).
  • Critical thinking and problem-solving skills.
  • Detail-oriented with a commitment to quality and accuracy.
This is a remote-first opportunity designed for professionals who thrive in a flexible work environment. If you are passionate about clinical research and seeking a challenging role with significant impact, we encourage you to apply.
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