924 Pharmaceutical Safety jobs in India

JOB DETAILS

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.

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

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 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company Overview

JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.

Job Overview

We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.

Qualifications and Skills

• Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
• In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
• Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
• Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
• Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
• Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
• Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
• Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.

Roles and Responsibilities

• Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
• Conduct regulatory assessments to determine applicable regulatory requirements for new products.
• Develop and implement regulatory strategies to support product development and compliance initiatives.
• Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
• Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
• Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
• Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
• Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.

Company Overview

JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.

Job Overview

We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.

Qualifications and Skills

• Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
• In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
• Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
• Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
• Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
• Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
• Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
• Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.

Roles and Responsibilities

• Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
• Conduct regulatory assessments to determine applicable regulatory requirements for new products.
• Develop and implement regulatory strategies to support product development and compliance initiatives.
• Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
• Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
• Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
• Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
• Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.