Pharmacovigilance Principal Scientist
Alphanumeric Systems
contract
Posted on:
Location Type: Remote
Location: Remote • 🇮🇳 India
Visit company websiteJob Level
Lead
Tech Stack
Vault
About the role
- Support Pharmacovigilance Management Systems for PV Operations.
- Contribute to all aspects of creation, maintenance, and achieving written standards for ICSR Management Team.
- Acts as a global PV Operations Leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
- Support PV Scientists with enhancement of knowledge and skills for ICSR Management, regulatory submissions, and oversight duties.
- Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements.
- Identify and assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs).
- Investigate and author deviations from established written procedures which include, root cause analysis (RCA), correction, corrective action and preventative action (CAPA) recommendations.
- Authoring investigations, RCA, CAPA for non-conformances from audit findings.
- Support trending analysis with third party service provider and clientGSK.
- Provide metrics for presentations.
- Recommend process changes to avoid repeat findings.
- Escalate identified problems or issues to the appropriate Management Personnel with PV Operations.
- Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
- Work with third parties/vendors to assist in development and implementation of robust processes to support quality-driven organization and in agreement with ICSR Management Team written standards.
- Prioritize work and time management, in line with business needs.
- Partners with third parties and PV service providers/vendors to design, implement, and monitor robust, quality-driven processes aligned with ICSR Management Team standards; support oversight activities such as audits, quality checks, and performance reviews.
- Assist in inspection and audit readiness activities, including preparation of documentation, subject matter expertise during health authority inspections, and follow-up on inspection observations.
- Support data integrity initiatives by ensuring consistent application of standards across safety systems, documentation repositories, and workflow platforms.
- Manage workload and priorities effectively to meet business needs, timelines, and evolving regulatory expectations; utilize project management skills to coordinate cross-functional deliverables.
Requirements
- Degree in life sciences or medical related field or previous experience equating to educational requirements.
- Hands-on experience in process development, optimization, and governance of PV written standards such as Standard Operating Procedures (SOPs), Work Instructions (WIs), Job Aids, Process Maps, and How-To Guides.
- Experience and strong understanding of CAPA, RCA, and structure follow up action plans.
- Demonstrated ability to map complex PV processes, translate operational requirements into clear documentation, and manage updates through formal quality systems.
- Practical knowledge of global pharmacovigilance regulatory guidelines (e.g., ICH, GVP Modules, FDA regulations) and experience working within safety databases or PV systems (e.g., Argus, ArisGlobal, Veeva Vault Safety).
- Experience in operational risk assessment, quality issue management, CAPA creation, and health authority/partner audit preparation is preferred.
- Strong written and verbal communication skills, with the ability to collaborate across global teams, influence decision-making, and support a culture of quality and compliance.
- Process development and maintenance of written standards, e.g. SOPs, Work Instructions, Job Aids, How To Guides, etc.
- Ability to map processes and author written standards.
- Knowledge and experience with pharmacovigilance systems.
Benefits
- 100% remote
- Project-based contract work
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
process developmentprocess optimizationgovernance of written standardsCAPARCAdocumentation managementoperational risk assessmentquality issue managementpharmacovigilance systemsdata integrity
Soft skills
time managementcollaborationinfluence decision-makingcommunicationproblem-solvingprioritizationproject managementattention to detailadaptabilitycritical thinking