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.
About The Job
Within the Consumer Safety Operations organization, under the direction of the Global Science Centre of Excellence (CoE) Lead, PSR Planning Expert is accountable for ensuring adequate worldwide regulatory planning of Periodic Safety Reports in compliance with International and Local regulatory requirements and as per provisions of Safety Data Exchange Agreements with Global external Partners to ensure continued marketing authorization of Opella products globally.
Main Responsibilities
PSR Planning Expert is responsible/accountable for the following:
- Develops Periodic Reporting plan with input from Affiliates. PSR Planning associate will work closely with PSR authoring lead under the guidance of Global PV Ops Head.
- Responsible for gathering, analyzing, consolidating and presenting key data and information required for effective planning and management of all activities related to periodic reporting.
- Ensure the planning is consolidated in a manner to meet all requirements and minimizing the number of reports written (thereby reducing the number of resources needed for writing reports and resources as assigned by Globval PV Ops).
- Prepare and maintain schedule of global periodic reporting requirements for all products worldwide based on local / international regulatory requirements.
- Participate in or lead relevant project teams/transversal projects.
- Provide direction and guidance to transversal teams for maintaining PSUSA list of PSRs.
- Oversee and manage the global periodic reporting platform interacting with Country PV organizations, Health Authorities, PSR Authoring Team, Clinical Evidence Team.
- Overall accountability for all Global PV Periodic Safety reports Planning and maintaining schedule.
Reporting Line
Reports directly to Global Safety Operations Group Lead, Hyderabad.
About You
Required Experience
- Master’s degree in pharmacy/Life sciences or HCPs with a minimum of 5 years of pharmacovigilance safety reports planning experience
- Strong knowledge of worldwide pre and post marketing safety reporting regulations and requirements and ICH guidelines
- Authored controlled procedural documents (i.e., SOPs, Master Templates, Technical Documents, etc.)
Required Skills
- Solid knowledge of GCP, ICH 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
- Excellent written and oral communication skills
- Ability to effectively work with others throughout the organization, primarily affiliates/Country PV organization
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
