489 Pharmacovigilance Manager jobs in India

• Preparation of aggregate reports including: PSUR, PBRER, PADER, DSURs, ACOs.
• Conduct quality review of aggregate reports, and quality review of reports generated by the vendor
• Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.
• Prepare data listings from the global safety database, where system access has been granted.
• Collate and provide data for RMP development and Signal Detection.
• Maintain and manage calendar for RMP and Signal detection.
• Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required
• Raise deviations to PV processes where identified
• Participate in development of CAPA and take ownership of CAPA completion where assigned
• Developing Pharmacovigilance (PV) training modules and organizing PV training for PV team members and other relevant staff.
• Collection of AE reports and other pharmacovigilance relevant data.
• Management of PV database.
• Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data.
• ICSR processing specifically reviewing MedDRA coding of data, assessment in terms of diagnosis and/or seriousness, Causality and seriousness assessment. Monitoring timely submission to regulatory authority.
• Literature search to identify relevant adverse event cases.
• Preparation/review of contractual arrangements with other persons/organizations with regards to pharmacovigilance obligations
• SDEA initiation with new parties and renewal.
• Assessing safety data and proposing risk minimization measures.
• Preparation/update/review of SOPs, PSURs, RMPs, contractual agreements etc.
• Review of compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance.
• Quality Management System: Oversee pharmacovigilance QMS and compliance activities for presentation at monthly compliance meeting and inclusion in monthly report as necessary.
• PSMF: Oversee the process for PSMF creation, review and update in conjunction with the Quality & Compliance Lead, and Regional Heads as key content contributors

Requisite for the role:

• Approx. 12 yrs of experience and Pharmacy degree, Post-Graduation is preferred.
• Cross function collaboration, with Medical, Regulatory and Commercial functions.
• Good understanding and knowledge of Pharmacovigilance requirements in India and adequate understanding in International and Emerging countries and regions.
• Line Management experience of Pharmacovigilance staff.

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.

JOB DETAILS

Job Description

• Develop and implement site-specific health & safety, policies and procedures.
• Ensure compliance with ISO 45001, BOCW Act, NBC, British Safety Council Five-Star, and other relevant standards.
• Conduct Detailed risk assessments and job hazard analyses for construction activities.
• Conduct regular site inspections on construction projects to ensure compliance with Occupational Health and Safety policies and local regulations.
• Identify unsafe conditions in construction activities and propose corrective actions to prevent incidents.
• Lead investigations for workplace incidents, near-misses, and dangerous occurrences and develop corrective and preventive actions.
• Maintain records of accidents and prepare reports for management and regulatory authorities.
• Develop and implement emergency response plans for construction projects.
• Evaluate and approve contractors based on their EHS performance & Monitor contractor compliance with site safety rules and legal regulations.
• Prepare and circulate safety inspection reports ensuring prompt communication of actionable outcomes.
• Collaborate with project managers and site supervisors to track and enforce critical construction safety standards.
• Monitor, analyze, and report on safety performance metrics, identifying trends and recommending continual improvements to foster a proactive safety culture.
• Coordinate with site team for organising safety training programmes & Site inspections.
• Oversee the installation, testing, and maintenance of fire and life safety equipment’s and ensure they are in working order across various facility premises.
• Conduct regular fire risk assessments and fire load calculations for buildings and sites.
• Develop and implement emergency response plans for fire incidents, evacuations, and other emergencies for all verticals of the business.
• Other responsibilities assigned by the reporting manager.

Position: Senior Manager – Safety

Experience: 10–15 years of relevant experience in product safety lab operations

Job Purpose

• To lead and manage the safety testing laboratory operations across multiple product categories, ensuring compliance with global standards and accreditation requirements.
• Drive team performance, quality assurance, and timely execution of testing projects.

Minimum Requirement:

• BE in Electronics / Electrical & Electronics Engineering
• 10–15 years of relevant experience in product safety lab operations.
• Hands-on exposure to global product standards and testing categories.
• Prior experience as Authorized Signatory for NABL/CBTL/NRTL/BIS/TEC.
• Certified Internal Auditor for ISO/IEC 17025 .
• Strong leadership, analytical, and decision-making skills.

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