Job title : PV Literature Surveillance Manager
About Opella
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.
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 .
About the role
This position has responsibility to ensure overall compliance for literature surveillance on a global basis and requires comprehensive understanding of global PV regulations including but not limited to EMA and USFDA regulations.
Main Responsibilities
- PV Literature Surveillance Manager is a critical member of the PV Operations team and reports to the Global Safety Operational Group Lead.
- This position includes responsibilities for the oversight of global Literature Screening in support of ICSR, Periodic Reporting and Signal/Risk Management.
- This position is responsible for liaising with PV Operations Head to provide the strategic vision, planning and oversight of PV Literature Surveillance.
- This position maintains oversight and responsibility for Literature procurement platform.
- Responsible for the medical evaluation of complex scientific and medical literature publications encompassing all types of publications including study publications for clinical studies - for all Opella products. These publications are identified from various sources available in international literature database utilizing approved screening criteria.
- The medical evaluation of the publications ensures high medical quality and compliance with health authority requirements regarding literature review and single case handling.
- Supervise and support the work of vendor team performing PV literature surveillance activities according to appropriate regulations and agreed processes.
- Perform end-to-end literature review and make the determination if the article is relevant for signal detection and/or inclusion in periodic reports and/or contains an ICSR (detection)
- Maintaining and documenting up-to-date product knowledge to aid in literature review
- Creating and maintaining literature search strategies (in house or in collaboration with vendors)
- Identifies critical case reports and other medical and scientific publications that require immediate attention of the Global Safety Leads/Managers.
- Serves as a mentor for Literature Reviewers of Contract Research Organization (CRO) for the accuracy of literature review result, case selection and correct documentation and provides expert guidance for the accurate medical assessment of literature publications to PV Case Processors.
- Responsible for management of Ad-Hoc Literature Searches.
- Ensures compliance with SOPs and health authority regulations by executing QC/QA steps regarding the Literature review and process.
- Performs ongoing quality checks of CRO literature review and literature case entry and provides feedback also for training purposes of the colleagues at the CRO.
- Continued interaction with all ICSR Processing, Periodic safety reports, Signal management, Pharmacovigilance agreements, CRO’s and Product Information Group to ensure high quality of literature review.
- Responsible for continuous process improvement activities related to area of responsibility.
- Responsible to maintain good documentation practice and be the Point of Contact in case of inspection/audit.
Latitude of Action:
- Oversee and manage the literature surveillance activities interacting with partners and customers within and outside of the Company, this includes Regulatory, Medical Safety, Case Management, and Periodic Safety Reporting teams.
Role Impact:
- This role will be the key contact point for countries and regions for all topics related to Global Literature surveillance.
- It requires experience in managing complex issues in a global environment.
- Overall responsible for all Global PV literature surveillance operations.
Scope:
- Overall management of timelines, quality and compliance of the Global PV literature surveillance operations.
Reporting Line:
- Reports directly to Global Safety Operational Group Lead at the Science GCC at Hyderabad.
Required Experience:
- Master’s degree in pharmacy/Life sciences or HCPs with a minimum of 5 years of relevant experience in pharmacovigilance/literature Surveillance or Bachelor’s degree in pharmacy/Life sciences or HCPs with 8+ years of relevant experience in pharmacovigilance/literature Surveillance.
- Knowledge of pharmacovigilance processes including global and local regulatory requirements.
- Must have knowledge of the EMA Medical Literature Monitoring (MLM) regulations, ICH principles of SAE/AE reporting along with an understanding of global regulatory rules and regulations and knowledge of safety policies and procedures in the major countries.
- Must have a good understanding of AE coding conventions (MedDRA)
- Authored controlled procedural documents (i.e., SOPs, Master Templates, Technical Documents, etc.)
Required Skills:
- Solid knowledge of ICH, GCP, GVP and Global regulations.
- Inspection and audit support, including readiness activities
- Demonstrated success in partnering and influencing across a matrix environment with exceptional executive communication skills.
- Ability to solve problems and take initiative, meet challenges, and strong negotiation skills
- Ability to work in a global, multi-entity, multi-cultural environment across time zones
- Excellent teamwork and collaboration skills.
- Pharmaceutical industry experience, especially in pharmacovigilance safety reports area
- Capability to organize and multitask activities, effectively prioritize and allocate resources
- Computer literacy especially in Windows based programs
- Ability to solve problems, to take initiative, to meet challenges, negotiation skills
- Fluent spoken and written English.
- Excellent written and oral communication skills.
- Ability to effectively work with others throughout the organization, primarily affiliates/Country PV organization.
- Ability to write/update/contribute to quality documents/job aids and developing training material to perform training to PV.
- Ability to manage and lead transversal meetings and small to moderate size groups and take appropriate decisions.
- Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural 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.
www.opella.com/en/careers
