Thermo Fisher Scientific is a leading global company in the field of scientific research and laboratory equipment. It provides a broad range of products and services to support scientific discovery and laboratory operations across various industries, including healthcare, pharmaceuticals, biotechnology, environmental, and industrial applications. Vacancy Details
- Location: Remote, India
- Job ID: R-01243764
- Job Type: Full-time
- Category: Clinical Research
- Remote: Fully Remote
Adverse Event Monitoring:
- Monitored and assessed adverse drug reactions (ADRs) and other safety events, ensuring timely and accurate reporting to regulatory authorities.
- Conducted thorough case reviews and medical assessments to determine causality and severity of reported events.
Regulatory Compliance:
- Ensured compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines, for the timely submission of safety reports.
- Prepared and submitted Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS) to regulatory agencies.
Safety Data Management:
- Managed and maintained pharmacovigilance databases, ensuring the accuracy, completeness, and confidentiality of safety data.
- Utilized advanced data analysis tools to identify safety signals and trends, providing insights for risk management and decision-making.
Risk Assessment and Mitigation:
- Conducted risk assessments to evaluate potential safety concerns and develop risk mitigation strategies.
- Collaborated with clinical teams to implement risk minimization measures and ensure patient safety.
Cross-functional Collaboration:
- Worked closely with clinical research teams, regulatory affairs, and medical affairs to integrate safety findings into overall project strategies.
- Participated in multidisciplinary meetings to discuss safety issues and ensure alignment with clinical development plans.
Training and Guidance:
- Provided training and guidance to internal teams on pharmacovigilance practices, regulatory requirements, and safety reporting procedures.
- Developed and updated Standard Operating Procedures (SOPs) and training materials to ensure consistency and compliance.
Incident Investigation and Reporting:
- Investigated and documented safety incidents, including conducting root cause analyses and implementing corrective actions.
- Coordinated with external stakeholders, including healthcare professionals and patients, to gather additional information and support safety evaluations.
Scientific and Medical Writing:
- Authored and reviewed safety-related documents, including clinical study reports, safety summaries, and regulatory submissions.
- Contributed to the preparation of scientific publications and presentations on safety findings and pharmacovigilance practices.
Key Responsibilities
- Pharmacovigilance Activities
- Collaboration
- Leadership
- Regulatory Updates
- Medical Understanding
- Quality Review
- Project Coordination
- Literature Surveillance
- Departmental Initiatives
- Audits and Inspection
Qualifications
- Education: Relevant Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field.
- Regulatory Knowledge: Thorough understanding of global pharmacovigilance regulations and guidelines.
- Skills:
- Strong analytical and problem-solving skills.
- Excellent written and oral communication skills.
- Proficient in using PV databases and other relevant IT applications.
- Ability to work effectively in a remote, team-oriented environment.
- Strong organizational and coordination abilities
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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