Global Pharmacovigilance Workflow & Oversight Manager

卡湯晩; Hyderabad; On-site; USD 80,000 - 1,50,000; Full time

Job summary

An established industry player is seeking a Global Pharmacovigilance Workflow & Oversight Manager to lead and optimize case management processes. In this pivotal role, you will ensure compliance with safety regulations and oversee a team dedicated to maintaining high standards in pharmacovigilance. You will engage with multiple stakeholders, drive process improvements, and contribute to the development of innovative solutions in the pharmaceutical sector. Join a dynamic team committed to enhancing health outcomes and making a meaningful impact in the industry.

Qualifications

• 6-8 years in the pharmaceutical industry with a focus on PV case processing.
• Experience managing teams and overseeing vendors in pharmacovigilance.
• Strong understanding of safety regulations and compliance.

Responsibilities

• Maintain case workload in PV databases and ensure timelines are met.
• Collaborate with internal departments and external vendors on safety matters.
• Monitor compliance and continuous improvement in PV processes.

Skills

Pharmacovigilance Database Management

Team Management

Vendor Oversight

Process Improvement

Stakeholder Management

Communication Skills

Analytical Skills

Time Management

Education

Bachelor’s degree in Pharmacy

Bachelor’s degree in Life Sciences

Tools

MS Office

Power BI

Spotfire

Job description

Global Pharmacovigilance Workflow & Oversight Manager

Job title: Global Pharmacovigilance Workflow & Oversight Manager

Main responsibilities:

1. Maintain case workload in CHAMPS (PV Database (DB)/LSMV) and ensure case timelines are met.
2. Maintain a healthy Work in Progress (WIP) case load for Opella.
3. Maintain business architecture diagram (all modules in LifeSphere).
4. Manage configurations for LSR tool.
5. Update LSMV (CHAMPS) user manual with current SOPs/regulations and case processing conventions.
6. Perform trending analysis and alert the case management head of abnormal case volume changes.
7. Monitor resource capacity utilization.
8. Engage regularly with multiple vendors related to Case Management (CM).
9. Collaborate cross-functionally with internal Opella departments and external resources on ICSR and safety DB matters.
10. Lead and define optimal business models to support business goals and meet KPIs for case processing vendors.
11. Ensure deployment of optimized processes for ICSR receipt, assessment, follow-up, data entry, medical evaluation, quality review, distribution, and submission, in compliance with SOPs/regulations.
12. Oversee compliance and continuous improvement in PV needs and processes.
13. Maintain operation reports from LifeSphere Reporting & Analytics (LSRA)/LifeSphere Multivigilance (LSMV) and implement CAPA plans for deviations.
14. Support QC and work with SMEs and QA to improve quality standards, identify process improvements, and ensure training and skills development.
15. Ensure availability of training materials and attendance for PV trainings.
16. Assist in CHC case migrations and monitor quality, timeliness, and documentation.
17. Participate in business continuity planning and implementation for PV operations.
18. Monitor processing, submission, and tracking of safety reports with regulatory authorities.
19. Contribute to process development and improvement initiatives.
20. Perform other PV tasks as required.

About you

Experience:

• Experience with PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV, etc.
• Case processing experience.
• Team management experience.
• Vendor oversight experience.
• Knowledge of safety/pharmacovigilance regulations, ICH GVP, and GxP systems validation.
• Proficiency in MS Office.
• 6-8 years in the pharmaceutical industry with at least 2 years managing a team.
• Strong ICSR quality review and submission experience.
• Process improvement skills.
• Stakeholder management, negotiation, and communication skills.
• Ability to operate effectively globally and cross-functionally.
• Time management and multi-project handling skills.
• Attention to detail, analytical, proactive problem-solving, and organizational skills.
• Excellent communication and interpersonal skills.
• Presentation skills for stakeholder and regulatory interactions.

Technical skills:

• Understanding of adverse event reporting and classification.
• Knowledge of global pharmacovigilance regulations and guidelines.
• Experience with safety reporting standards and compliance.
• Familiarity with GxP guidelines.
• Database management skills for safety systems.
• Advanced MS Office skills, especially Excel, Word, PowerPoint.
• Experience with BI tools like Power BI or Spotfire.

Education:

Bachelor’s degree in pharmacy, Life Sciences, or equivalent, with 6-8 years of experience, including 6 years in PV case processing.

Languages: Fluent in English (verbal and written).

Better is out there. Better medications, outcomes, and science. Progress depends on diverse people united by the goal to make miracles happen. At Sanofi, we support equality and are dedicated to human health.