PV Systems Operations Lead

Job title: PV Systems Operations Lead

• 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:

This position is Accountable to oversee all the PV Safety Configuration Team & SSDM Activities under the leadership of SSDM Head (Safety System & Data Strategy Management)

Main Responsibilities:

• This position is Accountable for resolving and escalating incidents, managing user requests in collaboration with Digital teams and PV Database hosting Vendor

• Handle discussions with business stakeholders to understand business requirements, document user requirements and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams based on the Roadmap from SSDM Head

• Communicate important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc

• Plan for scheduled/ad-hoc releases by developing and execution of test scripts. Work in close collaboration with Application Vendor/Digital teams for the implementation of all releases in ensuring GxP validation requirements are met.

• Ensure training materials are updated as releases move through the development and deployment process. Facilitate support and training sessions for system users.

• Maintain systems access and assessing any impact to systems security due to the introduction of new system features. Conduct regular access management reviews to remain in compliance with corporate security policies under the due diligence of SSDM Head

• Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed under the due diligence of SSDM Head

• Support oversight of vendor, monitoring of KPIs, assist with incidents and escalations as needed as part of governance structure.

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

• Support vendor teams in Configuration Changes needs, Testing & Deployments

• Work in an Agile environment

Latitude of Action:

• You will be guided by the SSDM Head towards the PV Strategies

• Your decisions will have direct impact on the reputation of the Sanofi CHC (Opella) in the market

• Your due diligence will contribute towards the Compliance Goals of PV organization

Role Impact:

• • This role will be the key contact point for peers in Opella PV organization for all topics related to the usage of shared systems and databases, ensuring that the Opella PV needs are met.

  • This position requires multiple interfaces with partners and customers within and outside of the Company.

  • It requires experience in managing complex issues in a PV Regulations & global environment.

Scope:

• Activities related to the PV System & Tools

About you:

Experience:

• Experience in PV Databases like ARGUS, ARISG, VAULT Safety etc.

• Experience in a systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager.

• Experience with leading safety systems.

• Experience and understanding of the safety/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 PL/SQL and MS Office.

• Minimum 10 years of pharmaceutical industry experience with a focus on pharmacovigilance. Strong experience in IS and validation is required. Incumbent should have experience in Process Improvement practices

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

·       Risk Management: Understanding risk management principles and how they apply to drug safety, including Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and Periodic Safety Update Reports (PSURs)

·       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.

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

·       Stakeholder Management: Ability to communicate with and manage relationships with various stakeholders, including pharmacovigilance teams, clinical development teams, and regulatory authorities.

·       Problem Solving: Proactively identifying issues within processes, systems, or data, and taking the initiative to solve them or propose improvements.

·       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).

·       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 :

• Degree in Science / Engineering or relevant Academic qualification is desirable with a minimum of 10 years of experience in GxP systems and PV databases

Language : Strong written & verbal communication skills in English language

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.