Global Pharmacovigilance Workflow & Oversight Manager

Job title: Global Pharmacovigilance Workflow & Oversight Manager

• Location: Hyderabad  

Main responsibilities:

• Responsible for maintaining case workload in CHAMPS (PV Database (DB)/LSMV) and ensuring the case timelines are within CHAMPS are met.

• Ensure to a maintain healthy Work in Progress (WIP) case load for Opella.

• Responsible for maintaining business architecture diagram (all modules in LifeSphere).

• Responsible for maintaining configurations for LSR tool.

• Maintain LSMV (CHAMPS) user manual with current SOPs/regulations and case processing conventions.

• Responsible for trending analysis and alert the case management head for any abnormal increase/decrease in case volumes

• Responsible for monitoring Capacity utilization of the resources.

• This role will regularly engage with multiple vendors in different roles and capabilities related to Case Management (CM).

• This role works cross functionally with internal Opella departments and external resources on ICSR and safety DB related matters.

• This role will lead and define optimal business models to support business goals and ensure the operational model meets defined strategic key performance indicators (KPIs) crucial to business success for case processing vendor.

• Ensure optimized process are deployed for ICSR receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution, and submission in compliance with SOPs/regulations.

• Provide ongoing oversight to ensure a consistent and compliant approach to understanding Opella PV needs and focus on continuous improvement to identify efficiencies.

• Maintains operation reports from LifeSphere Reporting & Analytics (LSRA)/ LifeSphere Multivigilance (LSMV) and ensures the implementation of effective CAPA plans for identified deviations in CM activities.

• Support QC lead and work closely with SMEs and Quality Assurance (QA) to improve and exceed quality standards, to identify process improvements and to ensure CM resources have necessary training and skills.

• Responsible to ensure training slides and attendance sheets for all PV trainings.

• Assists in CHC case migrations for divestments/ acquisitions and support monitoring quality & timeliness and complete documentation audit trail of DM.

• Participates in business continuity arrangements and assists with the authoring and implementation of PV Operations business continuity plan (BCP) processes.

• Collaborates with CHC PV ops leads, CSH and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.

• Participate in the development and continuous improvement of processes, workflow, and supporting documents.

• Other PV tasks as required.

About you

Experience:

• Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc.

• Experience in case processing activities.

• Experience in team management

• Experience in overseeing vendors responsible for case processing.

• Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation

• Good knowledge of MS Office

• 6-8 years of pharmaceutical industry experience with a focus on pharmacovigilance with min 2 years in managing team

• Strong experience in ICSR quality review and submissions

• Incumbent should have experience in Process Improvement practices

Soft skills:

• Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.

• Time Management: Ability to manage multiple projects and deadlines effectively, ensuring that safety reports and data analysis are delivered on time.

• Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.

• Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

• Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way

• Excellent team-work and interpersonal skills

• Ability to work in cross-functional teams

• Excellent oral and written communication skills

• Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way

Technical skills:

• Understanding of Adverse Event Reporting: Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports

• Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities.

• Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards.

• Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards.

• Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.

• Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings).

• Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders. 

Education:

Bachelor’s degree in pharmacy / Life Sciences / equivalent Academic qualification is desirable with 6-8 years of experience and min. 6 years in Global PV case processing activities

Languages: Fluent in English (verbal and written)