Regulatory and Pharmacovigilance Specialist

hace 6 días

Panamá, Panamá Guerbet A tiempo completo

**Regulatory and Pharmacovigilance Specialist**:
**At Guerbet, we build lasting relationships so that to enable people to live better**. This is **Our Purpose.**

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

**Achieve**, **Cooperate,** **Care **and **Innovate** are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

The Regulatory and Pharmacovigilance Specialist is an experienced professional with an extensive background in Regulatory (RA) and Pharmacovigilance (PV) and will ensure effective functioning of the areas in the region of Panama and Central America.

**Responsibilities include, but are not limited to**:
**Regulatory**
- Coordinate the preparation and assembly of regulatory submissions of medical devices and pharmaceuticals to ensure timely completion and filing as required across Central America Countries (CAC), including Panama.
- Act as Pharmacist in Charge for RA in Panama for the company.
- Where applicable, assist in-country regulatory consultants and/local distributors to ensure filling of regulatory submissions within the respective regulatory bodies.
- Develop regional maintenance submission strategies and plans during the life cycle of the products across the region (renewals, variations, notifications, withdrawals).
- Interact with local regulatory bodies where needed or through local in-country consultants to discuss project feasibility, strategies to achieve fast-track approvals and assess the impact of change control for the regional marketing authorizations
- Manage regulatory submissions tracking process establishing timelines for product maintenance submissions.
- Represent the Manager/Director in meetings of class entities and/or in meetings with health authorities, as delegated.
- Maintain internal processes in accordance with Regulatory, Quality, local and regional legislations, and global procedures.
- Coordinate the main regulatory stakeholders in the CAC, being Guerbet's point of contact for these external consultants, providing the necessary regulatory documents to ensure the implementation of regulatory projects in these countries.
- Assist the LATAM Regulatory Affairs Manager on regulatory projects for CAC.
- Provide regulatory support for other corporate areas.
- Analyze, translate, prepare, or adapt the technical documentation in accordance with the legislation in force for the registration, post-approval changes, processes, and certifications of good manufacturing practices, according to the reference documents, meeting the established deadlines.
- Monitor and perform review, update and maintenance for CAC packaging and labeling artworks workflow in compliance with regulatory authorities and headquarter datasheet.

**Pharmacovigilance and Materiovigilance**
- Act as Local Responsible Person for Pharmacovigilance (LRPPV) - Pharmacist in charge of PV and Local Responsible Person for Materiovigilance (LRPMV) for MV matters or requests from the Health Authority in Panama.
- In the absence of LRPPV and/or LRPMV from Colombia affiliate, act as LRPPV/LRPMV Deputy.
- Prepare, track, and submit to Headquarters (HQ) and the Local Health Authority (HA) all Pharmacovigilance/Materiovigilance (PV/MV) case reports received, and any other safety reports as required.
- Oversight all activities to ensure materiovigilance and pharmacovigilance compliance.
- Perform literature search and signal detection regarding adverse events related to Guerbet Products.
- Management and planning of local budget.
- Ensure the signing of Safety Data Exchange Agreements (SDEA).
- Assist in the evaluation of PV/MV SOPs maintaining internal processes in accordance with local legislation and global procedures, and all safety documents up to date.
- Represent the company in PV/MV matters with pharmaceutical associations and the Health Authorities in Panama.
- Ensures quality of PV/MV data posted to competent authorities, and assure the archiving of PV/MV documents are done in an accurate manner.
- Support PV/MV compliance on audits and CAPA management, and prepare the area for inspections.
- Provide training to employees and external stakeholders on PV/MV matters and on Safety Agreements.

**Education, experiences, and skills**
- Academic background: Pharmacist, Veterinarian or Biologist with an active registration in the respective Regional Council.
- Fluency in Spanish and English advanced is desirable.
- Project management skills and solid exp

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