78 Clinicalsafety jobs in India
Consultant - Process Safety Management (PSM)
Posted today
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Purpose Statement
We are looking for Process Safety Professionals having a strong combined background in Operations and Consulting of 20+ years’, to join our fast-growing Management Consulting business. Hands-on exposure to manufacturing operations, especially in high-hazard industries in line management, and EHS functional experience in consulting is highly desirable.
We are a dynamic organization with strong core values, and a fast-growing team with a differentiated focus on client outcomes. The incumbent is expected to be a high-energy, resourceful, analytical individual with strong communication skills and a passion for results. He / she will leverage expertise in process safety, risk management, and cultural transformation to create value for clients. The role requires working closely with subject matter experts and other dss team members to design and execute practical solutions that improve safety and operational reliability.
The person should be adept at applying risk-based and hypothesis-led approaches to identify focus areas quickly and implement effective interventions. Collaboration with project teams, clients’ leadership, and operations staff will be key to achieving the desired objectives. The consultant will also be expected to connect with our global network of experts, to design innovative safety solutions, and apply them to client situations.
With our strong and ambitious regional growth plans, this is an excellent time for passionate and skilled process safety professionals to join us. The right individuals will likely take on broader responsibilities beyond the core role, with significant opportunities for career growth within dss+.
Key Accountabilities
Consulting Project Delivery – Primary Focus Area
Create value for clients by framing safety challenges, conducting risk analyses, developing interventions, and supporting execution on the ground. Apply expertise in process safety techniques (HAZOP, LOPA, SIL, QRA, etc.) to strengthen client safety systems. Lead the implementation and improvement of PSM elements such as Process Safety Information, Process Hazards Analysis, Management of Change (MOC), PSSR, Asset Integrity, and Emergency Response Planning, etc. Work with stakeholders across all levels to drive safety culture and improve operational risk control
Support Business Development
Identify process safety opportunities during engagements and support business development teams in expanding client relationships
IP Development
Develop differentiated perspectives, POVs, and articles on process safety to help position dss+ as a thought leader
People Development
Inspire, role model, coach, and motivate team members and client stakeholders. Play an active role in developing the next generation of process safety consultants
Knowledge, Educational Qualification, Skills and Experience:
Bachelor’s degree in Engineering (Chemical / Mechanical highly preferred). A Master's degree in Engineering or an MBA will be an added advantage
20+ years of overall experience in high-hazard industries (Chemicals, Oil & Gas, Refining, Pharmaceuticals, Metals & Mining, etc.)
Knowledge of the latest trends in PSM and Digitalization
Significant leadership experience in Process Safety Management and / or consulting with a reputed EHS / PSM consulting firm. 20+ years of overall experience in the manufacturing industry, including:
(a). Senior leadership roles in Operations / Plant Management, leading multi-functional teams in Industry Sectors, e.g., Chemicals, Metals and Mining, Pharmaceutical, Oil & Gas, is a must
(b). Operations Risk Management (ORM) consulting or functional leadership experience, preferably with a reputed EHS Risk management consulting firm
Specifics:
Deep understanding of Process Safety Management elements, encompassing:
Management of Change (MOC) for technology, facility, and people, PSSR (Pre-Startup Safety Review / Authorization for Startup), Asset Integrity & Reliability – knowledge of inspection, maintenance, and mechanical integrity programs, Process Safety Information (PSI) covering chemical, equipment, and process documentation, Process Hazards Analysis techniques (HAZOP, What-If, LOPA, QRA, SIL, Facility Siting). Reaction Kinetics, Thermodynamics, and Heat/Mass Transfer fundamentals relevant to process hazards
Experience with both batch and continuous operations in design, operations, and safety reviews
Operating Procedures & Safe Work Practices, Emergency Response & Planning, Incident Investigation, PSM Audits
Demonstrated ability to drive safety culture transformation around mindsets and behaviours
Skilled in analytical problem solving, with advanced Excel and data modelling capabilities
Strong executive communication and presentation skills; PowerPoint proficiency required, Tableau or other visualization tools would be a plus
Executive presence, excellent interpersonal skills, and the ability to influence and engage clients at all levels will be required
Fluency in English, Hindi (both written and spoken) is expected + knowledge of at least 1 Regional Indian Language will be an advantage
Willingness to travel up to 75% of the time
Note: this job description is intended to present the most important characteristics of the position at a defined point in time. It is acknowledged that duties, objectives, and job requirements may change over time. If these changes become significant, a new job description should be written
Senior Aviation Safety Management Systems Specialist
Posted 18 days ago
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Remote Aviation Safety Management System (SMS) Specialist
Posted 4 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and manage the organization's Safety Management System (SMS) in accordance with ICAO Annex 19, relevant national aviation regulations, and industry best practices.
- Establish and maintain safety reporting systems, encouraging a non-punitive reporting culture among all personnel.
- Analyze safety data, incident reports, and audit findings to identify hazards and assess risks.
- Develop and implement effective risk mitigation strategies and corrective actions.
- Conduct regular safety audits and inspections to ensure compliance with SMS requirements.
- Facilitate safety action groups and risk management committees.
- Develop and deliver safety training programs to all levels of the organization.
- Promote a positive safety culture through effective communication, awareness campaigns, and leadership engagement.
- Maintain accurate safety records, documentation, and performance metrics.
- Liaise with regulatory authorities regarding safety matters and SMS compliance.
- Stay current with evolving aviation safety regulations, trends, and technologies.
- Provide expert advice on safety-related issues to management and operational departments.
- Contribute to the continuous improvement of the SMS through proactive identification of potential safety concerns.
Qualifications:
- Bachelor's degree in Aviation Management, Aerospace Engineering, Safety Science, or a related field.
- Minimum of 5 years of experience in aviation safety, with a strong focus on Safety Management Systems (SMS).
- In-depth knowledge of ICAO Annex 19, EASA, FAA, or equivalent aviation safety regulations.
- Proven experience in hazard identification, risk assessment, and mitigation planning.
- Familiarity with safety reporting systems and data analysis techniques.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Ability to work independently and manage multiple priorities in a remote setting.
- Proficiency in using safety management software and standard office applications.
- Relevant safety certifications (e.g., certified safety professional - CSP, aviation safety professional - ASP) are a strong asset.
- Demonstrated ability to foster a positive safety culture.
Project Manager (Clinical Trials)
Posted today
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Job Description
Project Manager (Clinical Studies)
**Business Unit:**
Clinical Research
**Location:**
Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Lead a team of clinical research professionals and collaborate with cross-functional stakeholders.
+ Develop and implement project plans, including timelines, milestones, and resource allocation.
+ Define project objectives, deliverables, and success criteria in collaboration with stakeholders.
+ Identify risks and develop mitigation strategies to ensure project success.
+ Allocate resources, assign tasks, and monitor team performance to ensure project goals are met.
+ Develop project budgets, track expenses, and ensure cost-effective utilization of resources.
+ Collaborate with finance and procurement teams to manage contracts, vendor selection, and outsourcing activities.
+ Monitor project progress and resource allocation to ensure efficient utilization and adherence to budgetary guidelines.
+ Ensure adherence to applicable regulatory guidelines, Good Clinical Practice (GCP), and other relevant standards.
+ Oversee the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
+ Implement quality control measures to ensure data integrity, accuracy, and compliance throughout the project
**Job Requirements**
**Educational Qualification**
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
**Experience**
Relevant experience of 5-10 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
+ Team Management and creating high performing teams
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
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.
Clinical Trials Disclosure Mgr
Posted today
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Job Description
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.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**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.
Senior Statistician - Clinical Trials
Posted today
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Job Description
About the Role:
This is an exciting opportunity to contribute to the development of innovative statistical methodologies and techniques as a Principal Biostatistician.
As a Principal Biostatistician, you will be responsible for providing statistical input into study protocols, case report forms, and data management plans, and contributing to study reports and clinical and statistical sections of regulatory submission dossiers.
You will also be responsible for generating innovative statistical methodology approaches and contributing to the development and visibility of the company's expertise and customer orientation.
Project Manager (Clinical Trials)
Posted today
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Job Description
Job Title:
Project Manager (Clinical Studies)
Business Unit:
Clinical Research
Location:
Mumbai
At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
Job Requirements
Educational Qualification
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
Experience
Relevant experience of 5-10 years minimum in the field of Clinical Research.
Additional Skills:
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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Clinical Research Associate (Clinical Trials)
Posted today
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Job Description
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Nagpur
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key 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
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
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.
Clinical Research Associate (Clinical Trials)
Posted today
Job Viewed
Job Description
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key 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
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
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.
Clinical Research Associate (Clinical Trials)
Posted today
Job Viewed
Job Description
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key 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
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
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.