Senior Full Stack developer (Java+Angular)-Tech Lead

Admiral Insurance Plc; Valencia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company seeks a PV Benefit-Risk Safety Writer to ensure the compliance and safety of its products. You will be responsible for authoring and managing safety reports, impacting regulatory submissions and overall patient safety. This role requires expertise in scientific writing, regulatory compliance, and strong communication skills, offering the opportunity to contribute to a world-class organization.

Servicios

Flexible benefits (childcare vouchers, employee discounts)

High importance placed on work-life balance

Commitment to an inclusive and diverse workforce

Formación

• Experience in pharmaceutical industry or related field.
• Prior experience in pharmacovigilance is a plus.
• Proficient in both primary language and English.

Responsabilidades

• Write aggregate safety reports for regulatory submission.
• Ensure compliance with regulatory standards.
• Lead cross-functional project teams on PV-RMP commitments.

Conocimientos

Excellent scientific/clinical writing

Strong communication abilities

Familiarity with medical terminology

Computer skills

Ability to perform detailed scientific analysis

Educación

Bachelor's degree in a medical/scientific field

Advanced degree (preferred)

Descripción del empleo

Vantive : A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive

• will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary :

We are currently looking for a PV Benefit-Risk Safety Writer to play a pivotal role in ensuring the safety and compliance of our pharmaceutical products worldwide. As the primary author of aggregate safety reports and risk management plans, you will have a direct impact on regulatory submissions and the success of our company. This is an exceptional opportunity to contribute to a world-class organization and make a difference in patient safety.

Responsibilities :

• Write standalone post-marketing aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), and associated reports, for regulatory submission.
• As the main writer, you will be responsible for creating PV-RMPs using different templates provided by the company, while ensuring compliance with regional and local regulatory standards.
• Perform quality control reviews of ASRs and PV-RMPs.
• Facilitate cross-functional document review and approval by other contributors.
• Ensure data issues are addressed and resolved prior to document sign-off.
• Ensure all assigned ASRs / PV-RMPs are processed and submitted according to regulatory requirements and internal timelines.
• Distribute ASRs / PV-RMPs for regulatory submission, to internal contacts and business partners per the established schedules and within regulatory requirements.
• Regularly observe compliance, maintain compliance data, and prepare metrics.
• Respond to queries / requests / assessment reports from regulatory authorities regarding ASRs and PV-RMPs.
• Lead cross-functional project teams tasked with activities related to the implementation, tracking, and effectiveness evaluation of PV-RMP commitments.
• Support the management in the establishment and maintenance of the ASR / PV-RMP schedules.
• Support the management in audits and inspections.
• Demonstrate solid understanding of the role of internal policies, conventions, and procedures in completing report assignments.
• Support the creation, improvement and maintenance of standardized departmental procedures and processes.
• Lead and participate on assigned project teams and committees.

Requirements :

• Equivalent experience in the pharmaceutical industry or a Bachelor's degree in a medical / scientific field; advanced degree and prior pharmaceutical industry experience is desired.
• Experience writing in an academic research, clinical research, scientific / analytical, or medical affairs setting is a plus
• Pharmacovigilance experience is a plus
• Excellent scientific / clinical writing and editorial skills
• Strong proficiency in both the primary language and English, with excellent verbal and written communication abilities.
• Familiarity with medical terminology and scientific writing
• Highly proficient computer skills and familiar with electronic publishing
• Solid understanding of pharmacovigilance regulation requirements for ASRs preparation, PV-RMPs, and drug approval processes
• Ability to perform detailed scientific analysis / evaluation of specialized information to support decision making
• Editing proficiency including experience with document formatting (spelling, punctuation, capitalization, paragraph indentation, organization, style and conventions) for submission readiness
• Demonstrate the ability to respond to and resolve inquiries and problems relating to assigned ASRs and PV-RMPs
• Ability to independently manage long- and short-term project timelines and deliverables.
• Experience in responding to queries / requests from regulatory authorities
• Thrives in a collaborative team setting with diverse perspectives

What we offer :

• High importance placed on work life balance (Family Responsible Certificate efr)
• Flexible benefits (childcare vouchers, employee discounts, etc.)
• Commitment to growing and developing an inclusive and diverse workforce

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