Clarivate is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world's most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise.
Post : Manager, Pharmacovigilance
Job Description
The Manager of Pharmacovigilance Content oversees all aspects of literature screening activities within the Pharmacovigilance department. This role requires advanced expertise in pharmacovigilance, including literature screening methodologies, signal detection, risk assessment, and team management skills. The Manager is responsible for developing and implementing strategies to ensure the efficient and effective identification of safety information from the scientific literature.
Oversee and coordinate all literature screening activities, including search strategy development, screening process management, and data extraction. Assists the Operations excellence activities related to operations and also supports Senior Manager/ Director in recruiting new members for the literature review team. Oversees the in-house training of new recruits and organizes regular refresher training sessions for the entire team. Manages communication and negotiation with customers regarding business operations as needed. Assesses the performance of trainees and keeps training records and documentation in a state ready for audit. Ensure the accuracy, completeness, and consistency of data extraction and documentation, providing guidance and support to the Literature Screening team. Lead the analysis of literature data to identify potential safety signals and emerging risks, applying advanced analytical skills and pharmacovigilance expertise. Prioritize signals for further evaluation based on clinical relevance and potential impact on product safety profiles. Conduct comprehensive risk assessments of identified safety signals, evaluating the potential implications for patient safety and contributing to risk management strategies. Develop and implement strategies for systematic screening of scientific literature to identify safety information relevant to pharmaceutical products. Establish best practices and standard operating procedures (SOPs) for literature screening activities, ensuring compliance with regulatory requirements and industry standards.
Collaborate with cross-functional teams to develop and implement risk mitigation measures as needed. Ensure compliance with regulatory requirements and internal SOPs in all aspects of literature screening activities. Oversees the Literature Screening team with a focus on quality and accuracy, providing mentorship and professional development, and conducting regular performance reviews. Ensures effective communication of findings to stakeholders and collaboration with cross-functional teams for safety updates and risk management. Leads the creation of a flexible training program, oversees data tasks, and emphasizes KPIs to support the team’s metrics and CAPA monitoring. Acts as a backup for the Senior Manager Pharmacovigilance when needed.
Candidate Profile
• Bachelor's degree/Master’s Degree in pharmacy, Life Sciences, Nursing, or related field. Advanced degree (e.g., PharmD, MD, PhD) preferred.
• At least 10 years of experience in pharmacovigilance or related fields within the pharmaceutical industry, with extensive experience in literature screening.
• In-depth knowledge of pharmacovigilance principles, adverse event reporting requirements, signal detection methodologies, and risk assessment principles.
• Strong understanding of pharmacovigilance regulations and guidelines (e.g., ICH, GVP) and experience with regulatory submissions.
Additional Information
Experience : At least 10 years of experience
Qualification : Bachelor's degree/Master’s Degree in pharmacy, Life Sciences
Location : Karnataka ; Noida, Uttar Pradesh, India
Functional Area : Life Sciences & Healthcare
End Date : 30th October, 2024
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