job title: Pharmacovigilance reporting analyst(opella)

Roles and Responsibilities

Main responsibilities:

• Lead & Participate in the Safety Report - Design & Development activities

• Support digital vendor teams in Compliance & Safety Reports Development, Testing & Deployments

• Use the data published across enterprise for effectively integrating data from various sources while generating Reports

• Maintain Validation of Safety reports generated from LSRA

• Plan & Prioritize deployment of safety reports as per business needs

• Support QPPV office with relevant reports for oversight activities

• Support incident & change management of LSRA, LSSRM, PSUR webpage tools

• Work with PV Country & Global Teams during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis

• Participate in discussions with business stakeholders to understand Reporting requirements, document them and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams

• Maintenance of existing reports on periodic basis and during System Upgrades

• Work alongside vendor assigned staff for existing safety database during transition period, assist with incidents and escalations as needed as part of governance structure

• Actively participate and contribute to the growing needs of Drug Safety Regulations

• Work in an Agile environment

Soft skills:

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

• 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.

• Experience in a CHC product and strategic development environment is essential. Previous experience leading a global organization including management of large multi-country budgets is essential.

• Excellent team-work and interpersonal skills

• Ability to work in cross-functional teams

• Excellent oral and written communication skills

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

Technical skills:

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.

Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades

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

Cross-functional Communication: Ability to collaborate with various departments (e.g., clinical, medical affairs, regulatory) and effectively communicate data insights and recommendations.  

Education:

Scientific background: Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable

Languages: Fluent in English (verbal and written)