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!

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