Compliance Lead – Clinical Safety & Pharmacovigilance
Location: Noida, India
Employment Type: Full-Time
Experience: 5–8 Years
About the Role
Soterius is seeking a detail-oriented and experienced Compliance Lead to oversee clinical safety and pharmacovigilance compliance across multiple projects. This role ensures adherence to operational, regulatory, and IT standards, supports audits and inspections, and provides training and mentorship to team members.
The Compliance Lead will work closely with internal teams and external stakeholders to guarantee that all activities comply with regulatory guidelines, client requirements, and industry best practices.
Key Responsibilities
Ensure compliance across assigned clinical safety and pharmacovigilance projects, including operational, regulatory, and IT domains.
Support ongoing adherence to quality standards, regulatory requirements, and industry guidelines.
Conduct continuous process improvements to enhance operational efficiency and compliance.
Record, review, and manage adverse reaction reports in safety databases for clinical trials and post-marketing activities, ensuring high accuracy and quality.
Own assigned projects to ensure timely and compliant deliverables.
Collaborate with internal and external stakeholders to maintain compliance with agreements, regulations, and guidelines.
Communicate effectively with stakeholders to support operational responsibilities.
Maintain complete and compliant documentation per Soterius and client processes.
Manage quality, compliance, and documentation standards across assigned projects.
Identify personnel or operational concerns that may impact quality and escalate appropriately.
Support audit and inspection activities and respond to regulatory queries as needed.
Train, mentor, and guide personnel on compliance and operational standards.
Identify training needs and assist in developing training materials relevant to pharmacovigilance and clinical safety functions.
Author, review, and update SOPs, work instructions, and other compliance documentation.
Perform administrative duties necessary for the role.
Required Skills & Qualifications
Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
Experience: 5–8 years in clinical safety, pharmacovigilance, or compliance roles, preferably in a pharmaceutical, clinical research, or healthcare setting.
Strong knowledge of global pharmacovigilance regulations, ICH GCP, and quality standards.
Experience supporting audits, inspections, and regulatory compliance activities.
Excellent communication, stakeholder management, and leadership skills.
Ability to train, mentor, and guide teams on regulatory and compliance processes.
High attention to detail, accuracy, and organizational skills.
Proven ability to manage multiple projects and meet deadlines in a dynamic environment.
Why Join Soterius
Lead high-impact compliance initiatives in clinical safety and pharmacovigilance.
Collaborate with global teams and gain exposure to regulatory audits and inspections.
Opportunity to mentor and develop teams while enhancing compliance practices.
Work in a dynamic, growth-oriented environment that values quality, accuracy, and innovation.
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