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Pharmacovigilance Reporting and Analytics Specialist

4 weeks ago

Hyderabad, India Opella Full time

Job title
:
Pharmacovigilance Reporting and Analytics Specialist

  • Location: Hyderabad

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

About The Job
Developing reports in Cognos, Power BI and LSRA and working in LSMV and PV process and regulations.

Main Responsibilities

  • Participate in Design & Development of the Safety Compliance & Reporting needs
  • 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
  • Understand the Case Submissions Lateness reasons and propose and implement CAPAs
  • Maintain Validation of Safety reports generated from LSRA
  • Implement deployment of safety reports as per business needs
  • Provide QPPV office with relevant reports for oversight activities
  • Support incident & change management of LSRA, LSSRM, PSUR webpage tools
  • Support 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
  • Participate in Report Automations using Dashboarding & Paginated Reporting tools & techniques
  • Actively participate and contribute to the growing needs of Drug Safety Regulations
  • Participate in any other assigned activities related to the PV domain
  • Work in an Agile environment

Experience
About you

  • Hands-on experience in custom reporting- report generation / development
  • Well-versed with Cognos & Power BI reporting as an end user
  • Experience in PV Databases like ARGUS, Aris-G (LSMV)
  • Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager
  • Programming languages like – Python, R, Javascript
  • 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 in Compliance Monitoring Tools
  • Experience with PV Signal Systems
  • Experience in handling the ICSR Submission Lateness reasons and CAPAs related to it
  • 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 Computer System Validation processes and using ALM
  • Good knowledge of MS Office
  • Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance reporting
  • Strong experience in IS and validation is required
  • 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.
  • 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.
  • 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

  • Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting Requirements.
  • Cognos & Power BI reporting as an end user
  • 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.
  • Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades
  • Report Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives.
  • 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 / Engineering or equivalent Academic qualification is desirable with 5 years' Technical Experience in GxP systems preferably in PV databases
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.