The Pharmacovigilance Lead will provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports AD, Clinical Development and Pharmacovigilance. Duties and responsibilities As the Pharmacovigilance Lead, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugen's clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen's studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives Interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports/submissions/queries. He/she independently addresses complex safety issues as a key decision-maker Provides strategic input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Degree in Medicine (MBBS, MD, Pharm D or equivalent) is required. Eight(3-8) years of pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. Eg. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing and verbal communication skills Ability to convey complex concepts through clear and concise messages Excellent problem solving skills, contingency planning and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.
