Pharmacovigilance Senior Specialist - Subject Matter Expert (SME) for ICSR Management - Remote Opportunity with a Global Pharmaceutical Brand

Join the Team: Pharmacovigilance Senior Specialist - SME for ICSR Management Alphanumeric is seeking a highly skilled and motivated Pharmacovigilance Senior Specialist - Subject Matter Expert (SME) for ICSR Management to work remotely in India on a 12-month contract with one of the world's leading pharmaceutical brands. As a key member of our Pharmacovigilance Operations team, you will play a critical role in supporting ICSR Management and driving high-quality documentation of processes and procedures. About Us At Alphanumeric, we pride ourselves on being a dynamic and innovative company that values collaboration, expertise, and customer satisfaction. Our team is dedicated to delivering exceptional results and making a positive impact in the pharmaceutical industry. With a global presence and a commitment to excellence, we offer a unique opportunity for professionals to grow and develop their careers. Job Purpose The primary purpose of this role is to support Pharmacovigilance Operations - ICSR Management. As a Pharmacovigilance Senior Specialist - SME, you will be responsible for contributing to the creation, maintenance, and archiving of written standards for ICSR Management. You will work across a complex matrix environment to drive high-quality documentation of all processes and procedures, ensuring compliance with internal standards and external regulatory requirements. Key Responsibilities Contribute to the creation, maintenance, and archiving of written standards for ICSR Management Team, including SOPs, Work Instructions, Job Aids, and How-To Guides. Work across a complex matrix environment to drive high-quality documentation of all processes and procedures, ensuring compliance with internal standards and external regulatory requirements. Identify and investigate root causes of problems or issues, and create corrective/preventative actions (CAPAs) to prevent recurrence. Escalate identified problems or issues to the appropriate Management Personnel with PV Operations. Generate new ideas and proposals for global implementation, contributing to the advancement of PV Operations methodology and processes. Collaborate with third parties/vendors to develop and implement robust processes that support a quality-driven organization and align with ICSR Management Team written standards. Support Technical Associates in enhancing their knowledge and skills for ICSR Management activities. Act as a global PV Operations subject matter expert for process discussions, including queries on strategy/policy-related decisions. Author or provide significant input into the development of written standards, including SOPs, Work Instructions, Job Aids, and How-To Guides. Prioritize work and time management in line with business needs. Education Requirements A degree in life sciences or a medically related field is required. Alternatively, previous experience that equates to educational requirements will be considered. Job Related Experience The ideal candidate will have: A minimum of 5 years of experience in process development and maintenance of written standards, such as SOPs, Work Instructions, Job Aids, and How-To Guides. Proven ability to map processes and author written standards. Knowledge and experience with pharmacovigilance systems, including ICSR Management. Strong analytical and problem-solving skills, with the ability to identify and investigate root causes of problems or issues. Excellent communication and interpersonal skills, with the ability to work effectively in a complex matrix environment. Skills and Competencies To succeed in this role, you will need: Strong knowledge of pharmacovigilance regulations and guidelines, including ICSR Management. Excellent written and verbal communication skills. Ability to work independently and as part of a global team. Strong analytical and problem-solving skills. Ability to prioritize work and manage time effectively. Strong attention to detail and ability to maintain high-quality documentation. Career Growth Opportunities and Learning Benefits At Alphanumeric, we are committed to the growth and development of our employees. As a Pharmacovigilance Senior Specialist - SME, you will have opportunities to: Develop and enhance your skills and knowledge in pharmacovigilance and ICSR Management. Contribute to the advancement of PV Operations methodology and processes. Collaborate with global teams and subject matter experts. Take on additional responsibilities and challenges. Work Environment and Company Culture We offer a dynamic and supportive work environment that values: Collaboration and teamwork. Innovation and creativity. Customer satisfaction and quality. Employee growth and development. Work-life balance and flexibility. Compensation, Perks, and Benefits We offer a competitive salary package commensurate with experience, as well as: Opportunities for professional growth and development. Flexible working arrangements, including remote work options. Access to cutting-edge technology and tools. A dynamic and supportive work environment. Conclusion If you are a motivated and skilled professional with a passion for pharmacovigilance and ICSR Management, we encourage you to apply for this exciting opportunity. As a Pharmacovigilance Senior Specialist - SME, you will play a critical role in supporting ICSR Management and driving high-quality documentation of processes and procedures. Join our team and take the next step in your career! Apply for this job