Benefit-Risk Management Expert

Job title: Benefit-Risk Management Expert

• 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

About the job:

The BME is responsible for leading the development of Structured Benefit-Risk assessment (B/R) models in close collaboration with stakeholders from other functions (e.g., pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistics, clinical operations, affiliates).

Main responsibilities:

• Advise on qualitative and quantitative B/R methodology and data sources; advise methods for collecting and incorporating external stakeholders' preferences (e.g., patients and physicians)
• Perform qualitative and quantitative B/R assessments in collaboration with other stakeholders
• Performs studies to collect external stakeholders' preference and incorporate the preference (weight) into B/R evaluation (e.g., physicians, patients)
• Prepare reports and communications of B/R evaluations
• Prepare responses to questions from health authorities related to quantitative B/R assessment
• Liaise with the other pharmaceutical companies and industry associations regarding collaborative studies as needed (e.g., for products with multiple market authorization holders)
• Management of data needed for the B/R model
• Identify data sources relevant for the questions being investigated and determine efficient data collection and analysis approaches that are suitable for the B/R model
• Perform additional analysis in RWE platform if needed
• Be a recognized Benefit-Risk Expert both internally and externally
• Be a point of contact and expert for B/R assessment in the company, notably for other functions such as Pharmacovigilance, Pharmacoepidemiology, Clinical development, Biostatistics, Clinical operations, Regulatory Affairs, Medical Affairs, Real-world evidence
• Keep abreast of changes in the regulatory, medical, scientific environment with respect to B/R practices and guidelines
• Participate in internal or external working groups on Benefit-Risk evaluation for process improvement, innovative methods development, and policy shaping

About you:

Education:

Preferred health care discipline degree in modern science: Master's in pharmacy, Master of Health Science, Physician Assistant, BDS etc

Experience:

• Minimum of 7 years of experience in pharmacovigilance or drug safety.
• Experience in consumer healthcare, pharmaceuticals, or related industries is preferred.
• Strong knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH) and benefit-risk management process and related tools.
• Proven track record of mentoring a team of PV professionals.
• Excellent networking and collaboration skills to interact transversally with numerous functions involved in benefit-risk management-related activities.

Required Skills:

• Ability to communicate complex medical clinical and pharmacovigilance issues and analysis orally and in writing.
• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a cross-functional team environment.

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.