PV Periodic Reporting Manager

Job title: PV Periodic Reporting Manager

• 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: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.​

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 four 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 to bring health in your hands at www.opella.com.​

About the job:

• Within the Consumer Safety Operations organization, under the direction of the Global Science CoE Lead, PV Periodic Reports Lead has overall accountability for all Pharmacovigilance (PV) periodic reporting, including Periodic Benefit-Risk Evaluation Report (PBRER) & Developmental Safety Update report. This individual must provide direction and guidance to transversal teams in developing the complex analysis of clinical study and post-marketing data as well as in responding to Health Authorities.
• Build working partnerships and relationships with cross-functional groups within and outside PV operations, including Global Safety Leads/Managers, Qualified Person for Pharmacovigilance (QPPV) and delegates, Global Case Management, Epidemiology, Global Regulatory Affairs, Clinical Operations, Global Medical Leads, Country and Regional Safety Heads, and contracted vendor organizations.
• Define, establish, and maintain global standards and expectations for periodic reporting based on expertise and awareness of Health Authority regulations on a global basis.

Main responsibilities:

This position has responsibility to ensure the overall compliance for Periodic Reporting on a global basis and requires comprehensive understanding of global PV regulations including but not limited to EMA and USFDA regulations.

Additional responsibilities include:

• Oversee and manage the global periodic reporting platform including personnel, activities from planning to distribution to appropriate stakeholders (Affiliates, Distributors, Business Partners).

• Provides strategic leadership in the content for global periodic safety reports (DSUR, PSUR) for Opella products.
• Provides guidance to staff regarding optimal practice regarding Periodic Report activities which includes Planning, Authoring, Coordination, Publishing, and Distribution.
  Develop and maintain infrastructure to support the Periodic Reports team, including development of operating plans, allocation of resources, schedules, and performance requirements are met.
• Responsibility for compliance with standard operating procedures (SOPs), global regulations/guidelines, corporate policies, and timelines.
• Lead the Periodic Benefit-Risk Evaluation Report (PBRER) Quality Governance for the Company.
• Drive collaboration and define contribution expectations with transversal contributors such as Regulatory, Medical, Clinical Operations and commercial partners.
• Ensure the timely authoring and reporting of high quality and consistent periodic safety reports that meet internal and regulatory requirements as well as provide customer satisfaction.
• Ensure the regulatory compliance for all managed activities concerning global reporting of periodic reporting to Health Authorities.
• Ensure appropriate outsourcing oversight is implemented for all periodic reporting activities across various team members.
• Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable.
• Act as product or process Subject Matter Expert (SME)
• Monitor performance trends and drive continue process improvements related to aggregate reports.
• Participate in or lead functional, departmental, and/or cross-functional projects and initiatives.

Latitude of Action:

Oversee and manage the global periodic reporting platform activities from planning to distribution to appropriate stakeholders (Affiliates, Distributors, Business Partners).

Role Impact:

Overall accountability for all Global PV Periodic Safety reporting, including Periodic Benefit-Risk Evaluation Report (PBRER) & Developmental Safety Update Report.

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.

www.opella.com/en/careers