Manager – Clinical Safety & Pharmacovigilance
Location: Noida, India
Employment Type: Full-Time
Experience: 8–12 Years
About the Role
We are seeking a highly skilled Manager – Clinical Safety & Pharmacovigilance to lead and oversee pharmacovigilance (PV) projects, including literature monitoring, case management, and team operations. This role requires strong leadership, regulatory knowledge, and expertise in clinical safety processes to ensure compliance, quality, and timely execution across PV projects.
Key Responsibilities
Project & Operations Management
Ensure effective functioning of PV projects (including literature monitoring, case processing, and team management) in compliance with client agreements, regulations, and internal SOPs.
Oversee assessment and review of literature abstracts and full-text articles for safety-relevant information with high accuracy and quality.
Take ownership of assigned projects and tasks, ensuring adherence to timelines and project deliverables.
Manage quality, compliance, and documentation across all assigned PV projects.
Team Leadership & Development
Provide line management for assigned personnel, monitor workloads, and ensure balanced task distribution.
Identify team training and development needs, and deliver mentorship to enhance performance and expertise.
Act as a point of contact for internal and external stakeholders to maintain regulatory and operational compliance.
Compliance, Audits & Documentation
Represent the department during audits, inspections, and regulatory reviews.
Author, review, and maintain SOPs, guidelines, and other department-relevant documents.
Continuously ensure compliance with agreements, applicable regulations, and industry standards.
Continuous Improvement
Support process improvement initiatives to optimize PV operations and enhance quality standards.
Escalate personnel or project issues to functional leadership to mitigate risks affecting PV project outcomes.
Undertake additional responsibilities as assigned by management to support organizational goals.
Required Skills & Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, or related field; advanced degrees preferred.
8–12 years of experience in clinical safety, pharmacovigilance, literature review, and team management.
Strong knowledge of global PV regulations and guidelines (GVP, FDA, EMA, ICH).
Proven experience in team leadership, mentorship, and cross-functional collaboration.
Excellent communication, analytical, and organizational skills.
Ability to manage multiple projects, deadlines, and regulatory requirements in a dynamic environment.
Why Join
Lead critical pharmacovigilance projects impacting patient safety and regulatory compliance.
Work in a fast-paced environment with opportunities to mentor and grow a high-performing PV team.
Contribute to the global healthcare and safety operations across clinical trials and post-marketing programs.
Gain exposure to audits, inspections, and quality improvement initiatives across the pharmacovigilance function.
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