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 Now
Apply Now