Thermo Fisher Scientific Hiring Fresher & Experience Safety Specialist In Pharmacovigilance (Work From Home )

Thermo Fisher Scientific is a leading global provider of scientific instruments, reagents, consumables, software, and services for research, analysis, discovery, and diagnostics. The company offers a wide range of products and solutions across various scientific disciplines, including life sciences, healthcare, and industrial markets.Thermo Fisher Scientific's offerings encompass laboratory equipment, analytical instruments, genetic testing solutions, laboratory consumables, and more. Their products are used by researchers, scientists, and healthcare professionals worldwide to advance scientific knowledge, improve patient outcomes, and enhance laboratory efficiency.The company is known for its commitment to innovation, quality, and customer satisfaction. It serves a diverse customer base, including academic institutions, pharmaceutical and biotechnology companies, hospitals, clinical laboratories, government agencies, and industrial laboratories

Vacancy Details

• Position: Safety Specialist In Pharmacovigilance
• Department: Clinical Research, Pharmacovigilance
• Education: B Pharm / M Pharm / PharmD / Bsc / Msc / Any life sciences graduates
• Job Lcation : Work From Home
• Experience : 1 Years
• Salary : Rs. 32000 Per Month

Responsibilities

• Monitoring and collecting information on adverse events (side effects) associated with the use of pharmaceutical products. This involves reviewing and assessing reports from healthcare professionals, patients, and clinical trials.
• Managing safety databases to accurately record and track adverse event reports. This includes data entry, coding, and ensuring compliance with regulatory requirements for data quality and integrity.
• Identifying potential safety signals or emerging risks associated with pharmaceutical products through data analysis and review of safety information. This involves conducting signal detection activities using statistical methods and pharmacovigilance tools.
• Assessing the potential risks and benefits of pharmaceutical products based on safety data and relevant scientific literature. This involves evaluating the severity and frequency of adverse events and making recommendations for risk mitigation strategies.
• Ensuring timely and accurate reporting of adverse events to regulatory authorities, such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency), in compliance with pharmacovigilance regulations and guidelines.
• Monitoring safety trends and patterns related to pharmaceutical products to identify any potential safety issues or changes in risk profiles. This may involve conducting periodic safety reviews and preparing safety reports for internal use or regulatory submissions.
• Developing and implementing risk management plans (RMPs) to minimize and mitigate identified risks associated with pharmaceutical products. This includes designing risk minimization strategies, such as product labeling updates, post-marketing studies, or risk communication activities.
• Collaborating with cross-functional teams, including clinical development, medical affairs, regulatory affairs, and quality assurance, to ensure a comprehensive approach to pharmacovigilance and risk management.
• Providing training and support to internal stakeholders, such as healthcare professionals and sales representatives, on pharmacovigilance processes, adverse event reporting requirements, and product safety information.
• Contributing to continuous improvement initiatives within the pharmacovigilance function, including process optimization, SOP (Standard Operating Procedure) development, and implementation of best practices to enhance safety surveillance and risk management processes.

Description

1. Adverse Event Monitoring:
   • Conducted thorough assessments of adverse drug reactions (ADRs) and adverse events (AEs) reported by patients and healthcare providers.
   • Implemented and maintained effective systems for capturing, tracking, and analyzing safety data to ensure patient safety and regulatory compliance.
2. Regulatory Compliance:
   • Ensured adherence to global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH standards.
   • Prepared and submitted detailed safety reports, including Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS), to regulatory authorities.
3. Data Analysis and Reporting:
   • Analyzed safety data to identify trends, potential risks, and safety signals, providing actionable insights to improve drug safety profiles.
   • Generated and presented safety summaries and recommendations to internal teams and external stakeholders, supporting informed decision-making.
4. Risk Management:
   • Developed and implemented risk management plans to mitigate identified safety risks and enhance patient safety.
   • Collaborated with clinical development teams to integrate safety findings into drug development processes and clinical trial designs.
5. Safety Audits and Inspections:
   • Conducted internal safety audits to ensure compliance with pharmacovigilance procedures and regulatory requirements.
   • Prepared for and managed regulatory inspections and audits, addressing findings and implementing corrective actions as needed.
6. Training and Education:
   • Provided training and guidance to clinical and regulatory staff on pharmacovigilance practices, safety reporting, and compliance requirements.
   • Developed educational materials and standard operating procedures (SOPs) to enhance understanding and adherence to pharmacovigilance protocols.
7. Collaboration and Communication:
   • Collaborated with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to address safety issues and improve processes.
   • Communicated safety information effectively to stakeholders, including healthcare professionals and patients, to support safe and effective use of medications.
8. Database Management:
   • Managed and maintained safety databases, ensuring accurate and timely entry of adverse event information.
   • Utilized advanced data management tools to facilitate efficient data collection, analysis, and reporting.
9. Process Improvement:
   • Identified opportunities for process improvements in pharmacovigilance practices and implemented strategies to enhance efficiency and data quality.
   • Leveraged technological advancements to streamline safety reporting workflows and enhance data accuracy.

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How to apply

click here to apply now :-Safety Specialist III job in Remote, India | Clinical Research jobs at Thermo Fisher Scientific

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