Senior Pharmaceutical Safety Specialist

2 days ago


Pune, Maharashtra, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 8,00,000
Job Description:
As a Senior Drug Safety Specialist, you will be responsible for collecting, tracking, and processing Adverse Events (AEs) from all sources with accuracy and efficiency. You will independently triage AEs to determine reportability in compliance with regulatory guidelines and clinical assessment standards.

You will code AEs using MedDRA and WHODRUG, applying clinical judgment to ensure correct categorization. Additionally, you will conduct quality control checks on case data to ensure accuracy, consistency, and completeness in safety databases and regulatory reporting forms.

In this role, you will work collaboratively with PV management, project managers, and internal teams to meet deadlines and project goals. You will also lead and mentor junior staff, including Drug Safety Associates and Drug Safety Coordinators, in case processing.

Furthermore, you will participate in the regular reconciliation of Serious Adverse Events (SAEs) between drug safety and clinical trial databases. This is an excellent opportunity to gain deep knowledge of client products and therapeutic areas.

To excel in this position, you should have a strong understanding of domestic and international regulations, including ICH and FDA guidelines. You should also be proficient in MedDRA and WHODRUG coding and have experience with safety database software.

We offer a challenging and rewarding environment where you can grow your skills and contribute to the success of our team.

  • Pune, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000

    Job Title: Pharmaceutical Regulatory SpecialistThe role of a Pharmaceutical Regulatory Specialist is to oversee the management of pharmaceutical and biological documentation, as well as registration applications for chemical active substances and biological medicinal products.Key Responsibilities:Ensure compliance with regulatory schedules as per the Drugs...


  • Pune, Maharashtra, India beBeeSoftware Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Senior Pharmaceutical Software SpecialistA highly skilled and experienced Senior Pharmaceutical Software Specialist is required to design, develop and configure software systems for pharmaceutical manufacturing processes. The ideal candidate will have expertise in MES recipe design and deployment, as well as a strong understanding of SDLC and pharmaceutical...


  • Pune, Maharashtra, India beBeeOperations Full time ₹ 15,00,000 - ₹ 20,00,000

    Lead Pharmaceutical Operations Specialist","Job Description:","As a key member of our operations team, the Lead Pharmaceutical Operations Specialist will oversee all aspects of pharmaceutical production, ensuring high-quality products meet regulatory standards. This includes developing and implementing process improvements, managing equipment maintenance,...


  • Pune, Maharashtra, India beBeeIntegration Full time ₹ 15,000 - ₹ 28,00,000

    Design and Integration SpecialistWe are seeking a highly skilled Design and Integration Specialist to join our team.The ideal candidate will have a strong background in vehicle safety design and experience with LS-DYNA and CATIA V5 for simulation and design tasks.Responsibilities:Collaborate with senior technical specialists to prepare homologation...


  • Pune, Maharashtra, India beBeeSeniorPricing Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Summary">A Senior Pricing Analyst will be responsible for managing and analyzing pharmaceutical pricing processes, ensuring timely delivery of reports and projects to clients. About the Role">Lead and manage a team of associates in charge of pharmaceutical pricing data analysis.Ensure that client data is accurate, up-to-date, and meets their specific...


  • Pune, Maharashtra, India beBeeProcessImplementation Full time ₹ 1,04,000 - ₹ 1,30,878

    Our team is seeking a Process Implementation Specialist to join our organization. As a key member of our team, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.The ideal candidate will have a strong...


  • Pune, Maharashtra, India beBeeDataDriven Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job SummaryYou will work as a detail-oriented and data-driven supply chain professional with experience in the pharmaceutical industry.Process Excellence SpecialistDevelop, review, and update Standard Operating Procedures (SOPs) aligned with cGMP and internal standards to ensure operational procedures meet regulatory requirements.Key ResponsibilitiesSupply...


  • Pune, Maharashtra, India beBeeProcessSafety Full time ₹ 10,00,000 - ₹ 20,00,000

    Job Description:Process Safety Specialist is responsible for ensuring the safety and integrity of onshore and offshore facilities.Key Responsibilities:Expertise in process safety for FPSO production facilities, gas processing systems, and oil separation units.Deliverables for project development, from conceptual to execution phases.Preparation of Hazardous...


  • Pune, Maharashtra, India beBeeChildSafety Full time ₹ 50,00,000 - ₹ 70,00,000

    Freelance Child Safety SpecialistAre you passionate about creating safer environments for children? We are seeking a Freelance Child Safety Specialist to join our team. This role is vital to ensuring children understand the importance of personal safety through our flagship program on Good Touch and Bad Touch.As a Freelance Child Safety Specialist, you will...


  • Pune, Maharashtra, India Steribio Lifesciences Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionSteribio Lifesciences Private Limited is a pharmaceutical manufacturing company focused on revolutionizing the production of parenteral solutions. We leverage imported technology alongside indigenously developed machinery to create a safer, more sterile, and cost-effective production process. By integrating advanced automation and...