RGP is a global consulting firm helping some of the most recognized companies in the world work differently. Our success comes from a shared belief in rolling up our sleeves and doing the hard work of solving complex challenges, executing plans and implementing technology to help transform organizations.
Working as a consultant, you will be connected to work that matters, putting your expertise to its best use while developing skills for the future. The result is a career defined by you, supported by RGP and built on tangible accomplishments.
As we continue to grow and deepen our impact on organizations around the world, we are looking for the right people to join us on our mission. If you are interested in being part of our team, there a few things you should know:
- We are energized by challenges and the effort needed to solve them.
- We like working with people who are positive, adaptable and growth-minded.
- We care how work gets accomplished and are deeply invested in the success of our clients and our colleagues.
If this sounds like you, we invite you to read on and learn more.
THE RGP CONSULTING EXPERIENCE
RGP has a unique consulting model that provides opportunities for consultants to work in different ways. Most consultants work in a model where they have the flexibility and autonomy to choose projects aligning to their experience, skills and desired lifestyle. Other opportunities exist in team-based, strategy and solutions work. In all models, you will feel the full support of RGP to assist you in your work and guide you on your chosen path.
ATTRIBUTES OF CONSULTANTS WITH RGP
- Respect for people and opinions and confidently offer your point-of-view with clients and among colleagues
- A drive for proactively cultivating relationships with clients and colleagues
- Optimism when faced with challenges and complex situations, coupled with the drive to solve client issues
- Dedication to continuous improvement and development of your skillset and talents
- A strong personal identification with RGP's values loyalty, integrity, focus, enthusiasm, accountability and talent
PURPOSE OF THE ROLE
- Responsible for managing Individual Case Safety Reports (ICSRs) and related pharmacovigilance activities to ensure compliance with global, regional, and local regulatory requirements for Singapore and Philippines, with potential support for other countries. This role includes oversight of vendors, cross-country collaboration, and continuous process improvement.
KEY RESPONSIBILITIES OF THE ROLE
Inbound & Outbound ICSR Case Management
- Monitor reportability and submit ICSRs to Competent Authorities and Business Partners within timelines.
- Receipt, assessment, and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
- Data entry for complex cases
- Performing follow-up requests for additional information from multiple sources.
- Assist in the quality review of data captured in the GIRS as applicable
- Verify and ensure translation of safety information, if applicable.
- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
- Vendor Management & Oversight
- Manage vendor relationships for case processing activities, ensuring adherence to contractual and quality standards.
- Conduct vendor training and provide ongoing support at case level.
- Perform daily or periodic vendor oversight, including case reviews and compliance checks.
- Collaborate with vendors to resolve issues and implement process improvements.
- Compliance & Quality Oversight
- Ensure accurate and timely documentation of deviations, root cause analysis, and CAPAs.
- Support LSO in reviewing new/revised PV regulations and assess impact on local processes.
Other Activities
- Ensure and support other case management related activities such as vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Periodic reconciliation activities
- Support LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
- Lead or support case management related innovation roll-out, in collaboration with the LMS Case Management Regional and Team leads
- Lead or support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
- Write or review ICSR related procedural documents and local memo implementation as applicable.
- Act as a mentor to junior staff and quality checking their work
- Lead or support critical project works
DESIRED EXPERIENCE AND REQUIREMENTS
- Education: Degree in Life Sciences, Pharmacy, or Medicine (preferred)
- Minimum 35 years in pharmacovigilance or related drug safety roles.
- Proven expertise in ICSR case processing, compliance monitoring, and regulatory reporting.
- Proven experience in Singapore and/or Philippines regulatory submission. Good understanding of clinical trial case submission.
- Demonstrated ability to apply global/local PV regulations and company procedures in daily case management activities.
- Familiarity with PV systems (e.g., GIRS, OST) and global/local PV regulations.
- Experience in vendor oversight and cross-country collaboration is highly desirable.
- Fluency in English language.
OTHER DETAILS:
Work Setup: Hybrid (2-3x weekly onsite)
Work Schedule: TBD
Work Location: BGC, Taguig
Equal Opportunity Employer
RGP is proud to be an Equal Opportunity Employer and committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, national origin, gender, pregnancy, sexual orientation, gender identity, physical or mental disability, genetic information or veteran status, and encourage all applicants to apply.
