Job title
:
Risk Management Expert
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 RME is responsible for developing global risk management strategies to optimize benefit-risk profile, for submission dossiers or marketed products with emerging safety risk(s), in coordination with relevant functions, developing corresponding RMP document.The SRME collaborates with Global safety leads/ managers and other stakeholders for the strategic design and planning of the Risk Management activities.
Main Responsibilities
- Accountable for risk management strategy to safeguard product safety profile and patient safety including risk management of the product.
- Lead any RMP (Risk Management Plan) Project from A to Z (initial submission, update)
- Handlle any HA (Health Authority) request regarding RM (Risk Management) activities
- Leading Working groups on Risk minimization strategies
- Collaborate with Medical and regulatory for their input in RM activities
- Coordinates administrative tasks and RMP documents (i.e., setting up the bibliographic references, list of abbreviations, document formatting, integration of comments, etc.) until final publishing by Operations department
- Responsible for RMP Quality Control (QC)
- Supports in authoring of parts and/or modules and/or sections of RMP document, preparation of annexes, RMP transferring from any previous old format into current new format/template, combination of 2 separate RMPs into one single RMP document
- Responsible for drafting and management of the minutes for the RMP meetings (such as submission Task Force, Kick Off Meeting (KOM), RMP draft consolidation meeting, or GRM-SG (Global Risk Management Supervision Group) as needed) and related to all the documents listed.
Education
About you
: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 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 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.www.opella.com/en/careers
