Pharmacovigilance Report Analyst

Grade : L2-1

Location : Hyderabad

Note : The requires a candidate with experience in PV Custom reporting, Power BI or any PV Database.

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.   

Our mission is to bring health in people's hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. 

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world's most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.  

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at  

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 

About you:

Experience:

Experience in PV Databases like ARGUS, Aris-G (LSMV) and Cognos & Power BI Reports. 

• Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager 

• Programming languages like – Python, R 

• DBMS skills – SQL, PL/SQL, Power BI – DAX 

• Development knowledge in AI/ML, LLM, NLP modules is preferred 

• Experience with development & analysis PV Reporting systems 

• Experience and understanding of Pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation

• Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems 

• Knowledge of validation processes 

• Good knowledge of MS Office 

• Minimum 6-8 years' pharmaceutical industry experience, experience in GxP systems preferably in PV databases with a focus on pharmacovigilance

• Strong experience in IS and validation is required

• Incumbent should have experience in Process Improvement practices

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.  

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)

Why us? 

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. 

We Are Challengers. 

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: 

All In Together: We keep each other honest and have each other's backs. 

Courageous: We break boundaries and take thoughtful risks with creativity. 

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. 

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. 

Join us on our mission. Health. In your hands.