235 Clinical Safety jobs in India

Drug Safety Associate-Reputed Tablet Manufacturing Industry-Bangalore, Bengaluru, Karnataka, Indi...

Bengaluru, Karnataka Seven Consultancy

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1)Needs to ensure that most of the safety reports that are received from the investigational sites or from the post- marketing sector must be identified & reported in accordance to the ICH-GCP standards & also by the standard operational procedures.
2)Reports that are collected must be organized based on the seriousness or effectiveness of the drug initially.
3)An overall consistency in assessing the adverse reaction reports must be accurate & legible.
4)Must be judgmental in taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations.
6)Must be able to communicate with clinical physicians in drug safety and assess case report forms.
7)Must be able to distinguish & analyze the ratio of risks & benefits of a drug that is marketed.
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Clinical Safety Associate- Vaf

ProductLife Group

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ProductLife Group is looking for a Clinical Safety associate to join our dynamic team to contribute to the activities performed in the Hub:
**Responsibilities**:
Processing of Adverse Events (AEs) / Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), and other immediately reportable events in the safety database including relevant communication with Customer
Query preparation, sending and follow-up
Maintenance of study trackers and other relevant tools
Reconciliation of clinical safety information/activities with Customer/CRO/Data Management
Assisting in aggregate periodic safety reports preparation
Assisting in expedited and periodic safety reports submissions
**Education and Experience**:
BSc or equivalent in Life Science discipline or PharmD
Experience in Pharmacovigilance/Drug Safety Data Entry
**Knowledge of databases (Safety database**: SafetyEasy)
Knowledge of drugs and pharmaceutical environment
Knowledge of Pharmacovigilance/Drug Safety regulation (national and international) and Pharmacovigilance tools
Demonstrable case management experience
**Skills**:
Adaptability
Analytical skills
Flexibility
Reliable
Good writing skills
Adept in using MS Office tools and Pharmacovigilance tools
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Clinical Safety Analyst-Reputed Clinical industry-Chennai, Tamil Nadu, India -4 Lakhs-Sonali

Chennai, Tamil Nadu Seven Consultancy

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1.approval of the Clinical Risk Management Plan, to confirm that the plan is appropriate and achievable in the context of Meds Companion
2.ensuring that clinical risk management activities are completed in accordance with the Clinical Risk Management Plan
3.reviewing and approving of safety documentation
4.reviewing of evidence in the Clinical Risk Management File,for completeness and support of the Clinical Safety Case Report
5.providing recommendation to Management regarding whether Meds Companion is safe to release
6.raising any unacceptable safety risks with Management be a suitably-qualified and experienced healthcare professional
7.hold a current registration with an appropriate professional body relevant to their training and experience
8.be knowledgeable in risk management and its application to clinical domains
9.have an understanding in the principles of risk and safety as applied to Health IT systems.
10.able to comprehend the nature of Meds Companion being developed, the human factors, and their contribution and control in the context of patient harm

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Manager, Clinical and Safety Analytics

Hyderabad, Andhra Pradesh Bristol Myers Squibb

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**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 .
This position is responsible for enhancing and developing a framework related to data analytics reporting utilizing metrics collected within the Worldwide Patient Safety & PV CoE Analytics function. The Analyst will enable analytical use of the compliance data that provides insights related to productivity, efficiency, and quality to facilitate informed decision making for BMS REMS & Clinical Analytics.
**Position Responsibilities**
? Responsible for ensuring compliance with regulatory requirements, enhancing drug safety and regulatory adherence with qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Regulatory, Medical & Clinical Safety, Commercial, Brand Marketing, etc.)
? Maintain and develop programming, reporting and analytics applications in BMS environments such as Spotfire, Tableau, Excel.
? Leverage internal data systems and tools to efficiently maintain data visualization, communications and reporting processes to minimize manual data retrieving
? Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions.
? Develop, Run, and maintain reports regarding activities, outcomes, and trends and be prepared to deliver presentations to management team on a regular and ad-hoc basis
? Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our REMS programs and reporting mechanisms
? Obtain a deep understanding of the prescriber and pharmacy operating environments through View Job Posting Details vendor and consulting interactions, stakeholder discussions, conference attendance, BMS events etc.
? Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
? Interpret and contextualize analytical findings documented by the REMS Advisor team
? Develop, Run and maintain reports and studies regarding Real world data analytics and present the outcomes to the stakeholders.
**Other tasks**
? Provide scheduled and ad-hoc reports to the leadership team as required
? Supporting Audit Activities related to BMS REMS & Clinical programs.
**Key Competency Requirements**
? Strong PowerPoint and Excel Skills
? Programming languages like SAS, SQL or Python etc.
? Strong knowledge and expertise in Tableau & and familiarity with Spotfire
? Databases (Salesforce, Postgres, Oracle, SharePoint List etc.)
? Ability to organize/curate data and see big picture from scattered pieces of information
? Analytical and strategic thinking skills required
? Familiarity and ability to navigate with Clinical and Real-world data
? Knowledge of Validation processes and associated documentation
? Excellent verbal, writing, presentation and project management skills
? Strong strategic orientation with ability to translate into operational priorities and plans
? Demonstrated ability to work on multiple projects
? Strong willingness to collaborate with cross-functional partners, flexible team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
? Confidentiality and integrity are required
? Strong work ethic a must
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:** R1591383
**Updated:** 2025-08-19 03:32:15.918 UTC
**Location:** Hyderabad-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 Trials Associate

Bengaluru, Karnataka Clinogenesis Research Institute

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**Job Title**: Clinical Trial Associate (Fresher)

**Company**: ClinoGenesis Research Institute
**Location**: Bangalore
**Employment Type**: Full-time

**Job Overview**:
We are hiring **fresh graduates** for the role of **Clinical Trial Associate (CTA)** in Bangalore. This entry-level position is ideal for individuals passionate about **clinical research, trial management, and regulatory compliance**. The role involves supporting clinical trial activities, ensuring compliance with regulatory guidelines, and coordinating research processes.

**Key Responsibilities**:

- Assist in the **coordination and execution** of clinical trials
- Maintain and update **trial documentation, protocols, and reports**:

- Ensure compliance with **ICH-GCP, regulatory, and ethical guidelines**:

- Collaborate with **investigators, sponsors, and regulatory bodies**:

- Support **site monitoring, patient recruitment, and data management**:

- Assist in audit preparations and quality control activities

**Eligibility & Qualifications**:

- **Bachelor’s/Master’s in Life Sciences, Pharmacy, Biotechnology, or related field**:

- Strong **analytical, organizational, and communication skills**:

- Ability to multitask and work in a team-oriented environment
- **No prior experience required** - full training will be provided

**What We Offer**:

- **Comprehensive industry training** on clinical research methodologies
- **100% placement assistance** in leading **CROs, hospitals, and pharmaceutical companies**:

- Hands-on exposure to **real-world clinical trials**:

- Professional development in **trial management, regulatory affairs, and pharmacovigilance**

**Job Types**: Full-time, Permanent

Pay: ₹14,519.52 - ₹32,607.72 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Work Location: In person
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Associate - PAI & Clinical Trials

Hyderabad, Andhra Pradesh Amgen

Posted 13 days ago

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**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will report to the Amgen India R&D Finance lead. The R&D Finance Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team.
+ FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
+ Support functional and consolidation teams in R&D finance
+ Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
+ Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
+ FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
+ Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
+ Handle Ad hoc requests: Providing accurate and timely support to stakeholders.
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
Master's degree and 0 to 2 years of accounting and/or finance (OR)
Bachelor's degree and 0 to 2 years accounting and/or finance (OR)
**Preferred Qualifications:**
Pharmaceutical / biotechnology industry experience
Knowledge and understanding of financial planning processes, quarter close activities
Strong analytical skills and exceptional attention to detail
Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good To Have Skills**
Big 4 and Fortune 500 FP&A experience
Capable of building models and financial reports
Technical finance knowledge and skills (accounting, planning, modeling, etc.)
Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)
Business partnering skills. Ability to work effectively in ambiguous situations and team environment
**Soft Skills:**
Effective analytical and communication skills (both verbal and written)
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Clinical Trials Disclosure Senior Associate

Hyderabad, Andhra Pradesh Amgen

Posted 13 days ago

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**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**What you will do**
+ Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information
+ Work closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
+ Communicate with team members to resolve problems and escalate issues
+ Record and maintain written redaction strategy for the study and product
+ Support trend analysis and process improvement
**What we expect of you**
+ 4-9 years experience in preparing regulatory documents for public disclosure
+ Familiarity with clinical research and clinical regulatory documents
+ Knowledge of clinical trial disclosure regulations, guidelines, and best practices
**Basic Qualifications:**
+ Experience understanding and interpreting data/information and its practical application
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Ability to follow controlled processes
+ Excellent spoken and written English
+ Ability to negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Specialist, Clinical Trials Strategy & Submission

Bengaluru, Karnataka AbbVie

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Array
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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Clinical Trials Pathology Services Supervisor

Prayagraj, Uttar Pradesh ACT Health

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Clinical Trials Pathology Services Supervisor (

Job Number:

 02NVH)
 

Description

Employment Type: Full Time, Permanent
Classification: Technical Officer Level 4 (PN 69694)
Salary: $100,650 - $14,448 (Plus 12% Super) 
Location:
The Canberra Hospital, Garran ACT
Section: Research Operations and Clinical Trials
Closing Date:
28 August 2025

What can we offer you: 

• 

Competitive pay rates and excellent working conditions within a tertiary hospital. 

• 

Salary Packaging with many options that provide full fringe benefits tax concessions.

• 

Flexible working conditions. 

12% Superannuation.

Access to Employee Assistance Program.

Access to discounted gym membership.

Access to onsite Physiotherapists.

Access to onsite cafes, staff cafeteria, pharmacy and gift shop.

• 

Up to $12K reimbursement of relo ation expenses for interstate candidates. (subject to review and approval)

About the Role:

The Clinical Trials Unit provides support for the conduct of clinical research at Canberra Hospital. The Unit currently has active trials in varying stages ranging from ethics submissions to trial close outs. The number of participants in each trial varies from approximately 1 to 1000 participants. These trials are either Pharmaceutical Sponsored trials, Collaborative or Investigator Led trials that are funded by grants such as the National Health & Medical Research Council.

The Clinical Trials Unit is establishing an in-house sample processing and coordination function to support the increasing volume and complexity of clinical research at Canberra Hospital. This newly created role will be responsible for coordinating all aspects of trial-related specimen handling, including processing, packaging, storage, transport, and documentation, in accordance with Good Clinical Practice (GCP) and sponsor requirements. The successful candidate will work closely with clinical trial coordinators, sponsors, couriers, and laboratory partners to ensure efficient and high-quality specimen management. With support of the management team, this position will play a key role in establishing new workflows, documentation, and relationships to support a scalable and sustainable service. Experience with specimen processing techniques (e.g., spinning, aliquoting, freezing), logistics coordination, and a strong understanding of trial protocols and regulatory requirements is essential. While the role does not initially have direct reports, it is expected to contribute to service development and future team expansion.

For more information regarding the position duties click here for the Position Description.

Please note prior to commencement successful candidates will be required to:

• 

Undergo a pre-employment National Police Check.

• 

Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.


To Apply: 

Please apply online by submitting a copy of your CV along with a 2-page cover letter or pitch, responding to the Selection Criteria, listed in the Position Description.

***Please note applications submitted via an agency will not be accepted for this position***

Canberra Health Services (CHS) is focussed on the delivery of high quality, effective, person centred care. It provides acute, sub-acute, primary and community‐based health services, to the Australian Capital Territory (ACT) and surrounding region. More information can be found on the CHS website. 

Our Vision : creating exceptional health care together 
Our Role : to be a health service that is trusted by our community
Our Values : Reliable, Progressive, Respectful and Kind

CHS is committed to workforce diversity and to creating an inclusive workplace. As part of this commitment, we welcome applications from all diversity groups. Aboriginal and Torres Strait Islander peoples, people with disability and people who identify as LGBTQIA+ are particularly encouraged to apply.

The new state-of-the-art Building 5 is now officially open at Canberra Hospital. This 44,000sqm, nine-storey facility, the largest healthcare infrastructure project in the Territory’s history, delivers cutting-edge acute clinical services. Building 5 seamlessly integrates with existing campus buildings, ensuring smooth public access, patient transportation, and efficient logistics.

If you would like further information regarding this opportunity, please contact Christopher Burton at .

#LI-DNI

Job

: General/Administrative

Salary Range

: 99,654.00 - 113,315.00

Closing Date

: 28/Aug/2025, 1:59:00 PM 

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Clinical Trials-Reputed Pharmacy Industry-Chennai, Tamil Nadu, India -3 Lakhs-Sonali

Chennai, Tamil Nadu Seven Consultancy

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JOB DETAILS


1.Creating and writing trial protocols, and presenting these to steering committee.
2.Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.
3.Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
4.Liaise with ethics committee regarding rights, safety and well-being of trial subjects.
5.Ordering, tracking, and managing IP and trial materials.
6.Overseeing and documenting IP dispensing, inventory and reconciliation.
7.Protecting subjects’ confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol.
8.Conducting regular site visits, coordinating project meetings and writing visit reports.
9.Implementing action plans for sites not meeting expectations.
10.Liaising with regulatory authorities.
11.Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
12.Other tasks and responsibilities as needed.
FUNCTIONAL AREA
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Health and Safety officer-Reputed Clinical Industry-Bangalore, Bengaluru, Karnataka, India-Upto 6...

Bengaluru, Karnataka Seven Consultancy

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JOB DETAILS


1)Ensure a safe workplace environment without risk to health.
2)Ensure that all Health & Safety policies, procedures, rules and regulations are adhered to and are regularly reviewed, updated and communicated.
3)Ensure the Company meets its statutory obligations in all areas pertaining to health, safety and welfare at work, including statutory training and reporting.
4)Ensure the completion and regular review of risk assessments for all work equipment and operations.
5)Ensure that all accidents are documented, investigated and recommended improvements implemented.
6)Ensure that safety inspections are carried out, fire drills and fire alarms are correctly reported, safety inspections, risk assessments and lone working procedures are managed and employees are aware of thei responsibilities.
7)Co-ordinate the development of health & safety policies, systems of work and procedures.
8)Ensure full and accurate health and safety and training records are maintained.
9)Establish a full programme of documented health & safety inspections, audits and checks.
10)Establish a structured programme of health & safety training throughout the Company.
11)Liaise with external health & safety consultants in the provision of training programmes and health and safety services.
12)Manage and devise the agenda for, chair and formulate & distribute minutes for the Health & Safety
FUNCTIONAL AREA
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