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Subject matter expert

2 weeks ago


Bengaluru, India Datafoundry Full time
JOB DESCRIPTION
Job Title : Subject Matter Expert (SME)
Department: Product Management
Experience: 10+Years Location : Bangalore
About Datafoundry:
Datafoundry is an AI first company with solutions to accelerate digital transformation. As part of our initial focus on the Life Sciences industry, we have built AI-automation products in the Safety Vigilance domain.
Datafoundry has multiple AI/ML algorithms that can solve digitalization problems across industry sectors such as Health Care, Utilities, Aerospace and Defence, Manufacturing, Banking and Financial sectors.
Position Summary:
We are seeking a Subject Matter Expert (SME) in Safety Products(Safety, Signal, Literature ) to provide specialized knowledge, guidance, and leadership within the pharmacovigilance product development team. You will leverage your deep understanding of safety data management, risk management systems, and regulatory compliance to support the design, implementation, and enhancement of our safety products. This role will involve collaborating with cross-functional teams and external stakeholders, ensuring that safety products meet the evolving needs of the pharmacovigilance domain.
Key Responsibilities:
Product Expertise: Serve as the go-to expert for safety products within the organization, providing guidance on the design, implementation, and improvement of pharmacovigilance safety systems, software solutions, and services.
Regulatory Guidance: Ensure that safety products are compliant with relevant regulatory requirements and industry standards, including FDA, EMA, ICH, Gx P, and others.
Collaboration: Collaborate with internal product development, engineering, quality assurance, and regulatory teams to define product features, enhancements, and roadmaps for safety products.
Customer Interaction: Engage with clients to understand their safety data management needs and provide product expertise to help them maximize the use of our pharmacovigilance solutions.
Market Insights: Stay current with trends and regulatory changes in pharmacovigilance, identifying opportunities for product innovation and improvement.
Risk Management: Advise on the development and implementation of risk management strategies in safety products, helping to assess and mitigate potential risks in the pharmacovigilance process.
Thought Leadership: Represent the company as an expert in safety products at conferences, webinars, and industry events, building the company’s reputation as a leader in pharmacovigilance safety solutions.
Documentation & Best Practices: Ensure that all safety product documentation (including user manuals, training materials, and regulatory submissions) is accurate, up to date, and aligned with industry best practices.
Skills & Qualifications:
Education: A degree in Life Sciences, Pharmacy, Pharmacovigilance, or a related field. A Master’s degree or equivalent experience is a plus.
Experience:
At least 10+ years of experience in pharmacovigilance, with a focus on safety data management or safety product development.
Proven experience working with pharmacovigilance safety solutions or software (e.g., ARISg, Oracle Argus, Veeva Vault QMS).
In-depth knowledge of pharmacovigilance processes, safety signal detection, risk management, and regulatory requirements.
Subject Matter Expertise: Extensive understanding of safety data collection, analysis, and reporting, as well as the ability to advise on complex safety-related product matters.
Regulatory Knowledge: Expertise in global pharmacovigilance regulations (FDA, EMA, ICH, Gx P) and standards related to drug safety and risk management.
Technical Skills: Familiarity with pharmacovigilance software, databases, and tools (e.g., pharmacovigilance databases, safety signal detection software).
Communication Skills: Exceptional verbal and written communication skills, with the ability to clearly convey complex technical information to both internal teams and external stakeholders.
Problem-Solving: Strong analytical and problem-solving skills to address challenges related to safety data management and product development.
Project Management: Ability to manage and prioritize multiple projects, ensuring that deadlines are met and high-quality deliverables are achieved.
Leadership: Ability to provide expert advice and mentorship to colleagues and clients on safety product-related matters.
Preferred Qualifications:
Certifications: Certification in pharmacovigilance or product management is a plus (e.g., PV certification, PMP, or Agile).
Industry Networking: Strong network within the pharmacovigilance community, including connections with regulatory bodies, industry organizations, and thought leaders.
Advanced Knowledge of Safety Signals: In-depth understanding of safety signal detection techniques, risk minimization strategies, and post-marketing surveillance.
Join our team at Datafoundry to be part of an exciting journey as we revolutionize the way organizations leverage data to gain a competitive advantage. We offer an attractive compensation and bonus package, a flexible remote work environment, and ample opportunities for professional growth.
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