Signal Management Expert at Opella

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Signal Management, Data Mining, Collaboration, Training, Regulatory Knowledge, Analytical Skills, Problem Solving, Communication, Mentoring, Cross-Functional Teamwork, Scientific Guidance, Quality Control, Report Generation, Stakeholder Engagement, Compliance

Industry

Retail Health and Personal Care Products

Description

Job title: Signal 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 www.opella.com. About the job: The SME is responsible for executing strategic guidance and expertise provided by Signal and Risk Management Lead, for the development and maintenance of excellence in signal management. The role is responsible for compliance with Signal Management rules and regulations worldwide and ensures that cross-functional teams are properly trained. The SME components of activities and works in close collaboration with different roles and function in implementing a consistent signal management process. Main responsibilities: Provide Signal Management Operational Activities: day-to-day operational input and support to relevant Signal Management stakeholders and maintain compliance. Provide training to GSOs, PVSs, and other stakeholders on the process and utilization of tracking system/tool. Provide scientific/methodological guidance related to signal detection at a program level. Collaborate with GSOs and PVSs stakeholders for the strategic design and planning of the signal detection activities. Responsible for strategically supporting routine, ad hoc, and issue investigations with regards to signal, in particular data mining. Signal detection expertise on both internal and external safety databases. Generate and distribute Signal Management Reports: periodic KPIs (Key Performance indicator) and metrics reports, QC (Quality check) reports, reports to inform PV management, including the QPPV, and any ad hoc reports within the scope of Signal Management. Provide Subject Matter expert support for Inspections and audits Monitor Opella's Signal Management mailbox Act as Safety Management Committee coordinator Perform manual QC of signal management Responsible for daily immediate notification reports (INRs) and monthly non-immediate notification reports (NINRs). About you: 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 signal 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 signal 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. Education: Preferred health care discipline degree in modern science: Master’s in pharmacy, Master of Health Science, Physician Assistant, BDS etc. 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 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 www.opella.com. Privacy Notice

Responsibilities

The Signal Management Expert is responsible for executing strategic guidance in signal management and ensuring compliance with global regulations. This role involves providing operational support, training stakeholders, and generating reports related to signal management activities.