Organon - Pharmacovigilance & Regulatory Affairs

hace 1 semana

Panama Organon A tiempo completo

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it

The Specialist is responsible for all Pharmacovigilance and Regulatory Affairs submission requirements and Pharmacovigilance activities for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.

The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local Pharmacovigilance and Regulatory Affairs agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with Pharmacovigilance requirements, authoring/reviewing Standard Operating Procedure, training, communication of safety issues, developing product registration plans and strategies.

**Primary Responsibilities**:

- Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
- Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual Case Safety Reports including tracking and translation to English and forwarding of information to the Data Management Center.
- Responsible for execution of local Pharmacovigilance and Regulatory Affairs processes and activities in alignment with Pharmacovigilance and Regulatory Affairs systems and their associated Quality Management System, following department Standard Operating Procedure, company Policies and Procedures and country legislation
Performs reconciliation activities for Pharmacovigilance cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ pharmacovigilance legislations
- Provides support for Patient Support Programs and/or Market Research vendor(s) related activities, as applicable
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality Pharmacovigilance and Regulatory Affairs data and evaluates processes for potential improvement in efficiency and effectiveness.
- Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.
**Qualification, Skills & Experience**:

- BS in Health, Life Science, or Medical Science degree or equivalent by education/experience.
- Minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs.
- General knowledge of pharmacovigilance and regulatory Affairs regulations within his/her assigned country
- CENCA experience
- Expert in pharmacovigilance and regulatory affairs processes/activities.
- Experience with Project Management
- Effective communication skills in English and Spanish, spoken and written.

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.

Our Vision is clear**:A better and healthier every day for every woman.**

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At Organon, we all belong. We embrace diversity and give it a voice.

Our com

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