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.
What will you be doing in this role?
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.
What you will need:
About Team:
Pharmacovigilance team at Clarivate provides services to multiple global customers covering all therapeutic areas. It provides a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and customer engagement
Hours of Work
The team is based out of India (Bangalore ). Monday-Friday. Hybrid work mode
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.