Are you passionate about advancing clinical research and ensuring patient safety? ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a talented Safety Scientist to join our innovative team in Bangalore, India. This full-time role, offering flexibility to work from the office or home, is perfect for professionals eager to contribute to pharmacovigilance, safety surveillance, and risk management in cutting-edge clinical trials. Join us to shape the future of healthcare with a career that combines scientific expertise, regulatory compliance, and collaborative innovation.
Key Responsibilities
As a Safety Scientist at ICON plc, you will play a critical role in ensuring the safety of clinical trial participants and contributing to regulatory compliance. Your responsibilities will include:
- Conducting Safety Surveillance: Review and interpret safety data for assigned projects, ensuring timely and accurate analysis.
- Collaborating with Teams: Partner with cross-functional teams to maintain participant safety and meet regulatory standards.
- Developing Safety Plans: Contribute to the creation and implementation of safety management plans and risk minimization strategies.
- Participating in Safety Reviews: Provide expert input during safety review meetings and support regulatory submissions with safety-related documentation.
- Leading Pharmacovigilance Activities: Oversee operational tasks as the functional pharmacovigilance (PV) team lead, assisting in client meetings and discussions requiring advanced expertise.
- Literature Search and Review: Author plans for routine pharmacovigilance, local literature, and aggregate safety analysis, defining search parameters and conducting reviews.
- Aggregate Safety Report Generation: Coordinate and generate reports, including data collection, querying, and interfacing with clients and safety writers.
- Signal Detection and Management: Develop and document signal detection strategies, manage source data, and generate signal detection, validation, and assessment reports.
- Risk Management: Support the development of risk management plans (RMP), risk evaluation and mitigation strategies (REMS), and track commitments.
- Maintaining Compliance: Assist with pharmacovigilance system master files (PSMF), key performance indicators (KPIs), audits, and inspections.
- Process Improvement: Contribute to the development of standard operating procedures (SOPs), templates, and training courses for pharmacovigilance.
Qualifications
To excel in this role, candidates should possess the following qualifications:
- Education: Bachelor’s degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
- Experience: Proven experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry.
- Knowledge: Strong understanding of pharmacovigilance principles, regulations, and guidelines (e.g., ICH, GVP).
- Skills:
- Excellent analytical and critical thinking skills to interpret complex medical data.
- Strong communication skills for effective collaboration with cross-functional teams.
- Detail-oriented with the ability to thrive in a fast-paced environment.
- Attributes: Ability to manage changing priorities and deliver high-quality results under tight deadlines.
Benefits of Joining ICON plc
At ICON plc, we value our people and foster a diverse, inclusive culture that drives innovation. As a Safety Scientist, you’ll enjoy:
- Competitive Salary: A rewarding compensation package tailored to your expertise.
- Flexible Work Options: Choose to work from our Bangalore office or remotely from home.
- Comprehensive Benefits:
- Generous annual leave entitlements.
- Health insurance plans designed for you and your family.
- Retirement planning options to secure your financial future.
- Access to the Global Employee Assistance Programme (TELUS Health) for 24/7 support.
- Life assurance for added peace of mind.
- Flexible, country-specific benefits such as childcare vouchers, gym memberships, and more.
