Alphanumeric Systems

Pharmacovigilance Principal Scientist

Alphanumeric Systems

contract

Posted on:

Location Type: Remote

Location: India

Visit company website

Explore more

✨ AI Apply
Apply

Job 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 & Tools
process developmentprocess optimizationgovernance of written standardsCAPARCAdocumentation managementoperational risk assessmentquality issue managementpharmacovigilance systemsdata integrity
Soft Skills
time managementcollaborationinfluence decision-makingcommunicationproblem-solvingprioritizationproject managementattention to detailadaptabilitycritical thinking