Medical Safety Operations Expert
Há 7 dias
Job Overview
About OrganonWe are a global healthcare company focused on delivering ingenious health solutions that enable people to live their best lives. Our vision is clear: A better and healthier every day for every woman.
We welcome applications from candidates with a diverse background, committed to creating an inclusive environment for all our applicants.
Annualized Salary Range$170,000 - $200,000 per annum
Based on location and experience.
Job DescriptionWe are seeking a skilled Medical Safety Operations Expert to join our team. The ideal candidate will have a minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV regulations within his/her assigned country and be an expert in PV processes/activities.
The incumbent will be responsible for the intake of cases received from designated points of contact, vendors, and business partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center.
He/she will also perform ICSR acknowledgments and reconciliation activities, execute local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company policies and procedures and country legislation.
In addition, he/she will provide support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities as applicable, file, store and archive safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
The Medical Safety Operations Expert will also act in full compliance with global and local SOPs, report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
Supporting local PV audits and inspections including readiness activities and supporting other audits/inspections including the development of CAPAs in response to findings/observations is also a key responsibility.
This role requires strong communication and time management skills, with the ability to work effectively in a team environment.
Required Skills and QualificationsEducation / Certificates:
- A health, life science, or medical science degree or equivalent by education/experience
- Fluent in English (written and spoken)
- Proficient in local language
Experience:
- A minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs
- General knowledge of PV regulations within his/her assigned country
- Expertise in PV processes/activities
Skills:
- Strong communication and time management skills
- Ability to work effectively in a team environment
We offer a competitive salary range, comprehensive benefits package and opportunities for professional growth and development.
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