Senior Manager, Drug Safety Physician

Vantive; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Multisport card

Holiday bonus

Annual bonus

Newborn bonus

Language courses

Hybrid work model

Job summary

Vantive is seeking a Medical Safety leader to oversee the ongoing safety profile of medicinal products across their lifecycle. You will evaluate safety data, support regulatory safety submissions, and provide medical input to the EU/UK QPPV.

In this role you will run safety case reviews, participate in signal detection, lead benefit–risk evaluations, and collaborate with regulatory, clinical, and quality teams. Hybrid work model in Warsaw with comprehensive benefits.

Qualifications

• Proven experience in medical safety evaluation and risk assessment.
• Strong knowledge of GVP, ICH, EMA, MHRA guidelines.
• Ability to collaborate with regulatory, clinical, medical affairs, and quality teams.
• Excellent analytical and leadership skills.

Responsibilities

• Perform medical review of ICSRs and safety data from trials, post‑marketing and literature.
• Participate in signal detection, validation, prioritization and documentation.
• Lead or support ongoing benefit–risk evaluations of assigned products; contribute to PSURs, RMPs, and safety documents.
• Contribute to regulatory submissions and responses to safety queries; support CDS/SmPC/PIL maintenance.
• Provide medical safety expertise to cross‑functional teams (clinical development, regulatory, quality, epidemiology).
• Identify opportunities for PV process improvements and SOP updates.

Skills

Pharmacovigilance

Regulatory knowledge

Cross-functional leadership

Clinical judgment

Communication (English)

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Role Overview

The position plays a critical role in ensuring the ongoing safety profile of the company’s medicinal products throughout their lifecycle. This position is responsible for the medical evaluation of safety data, benefit risk assessments, signal detection activities, and contributions to regulatory safety submissions. The role requires strong clinical judgment, expertise in pharmacovigilance principles, and the ability to collaborate cross functionally with regulatory, clinical, medical affairs, and quality teams. This position will also provide medical support to the EU/UK QPPV.

What You’ll Do

Safety Case Evaluation

• Perform medical review of individual case safety reports (ICSRs), including serious and non‑serious adverse events from clinical trials, post‑marketing, literature, and partner sources.
• Provide medically sound coding, causality assessment, expectedness assessment, and clinical interpretation.
• Ensure compliance with global regulations and internal timelines.

Signal Detection & Risk Assessment

• Participate in routine signal detection activities, including review of statistical outputs and aggregate data.
• Contribute to signal validation, prioritization, assessment, and documentation.
• Make clinical recommendations on further analyses, risk mitigation, and regulatory actions.

Benefit‑Risk Evaluation

• Lead or support the ongoing benefit–risk evaluations of assigned products.
• Provide medical input to Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and safety‑related clinical documents.
• Collaborate with the QPPV (if applicable) and Safety Specialist to ensure accurate product safety profiles.

Regulatory Interaction & Documentation

• Contribute to regulatory safety submissions, including responses to Health Authority safety queries, Dear Healthcare Provider letters, and safety variations.
• Support the creation and maintenance of core safety documents (CDS/SmPC/PIL).
• Participate in regulatory inspections and audits as a subject matter expert for medical safety.

Cross‑Functional Collaboration

• Provide medical safety expertise to clinical development, medical affairs, regulatory affairs, quality, epidemiology, and commercial teams.
• Serve as the safety representative on cross‑functional project teams.
• Support development of safety‑related training materials for internal stakeholders.

Compliance & Process Improvement

• Ensure adherence to GVP, ICH, EMA, MHRA, FDA, and other relevant global pharmacovigilance regulations.
• Identify opportunities for process optimization and contribute to SOP development and updates.
• Uphold a culture of safety, compliance, and scientific rigor.

What You’ll Bring

• - Ability to liaise effectively with the different functions involved, e.g., Quality Assurance, Medical Affairs, Clinical, Medical Information, Regulatory Affairs, Sales and Marketing, etc.
• - Broad understanding of the global PV environment.
• - Excellent analytical and problem-solving skills.
• - Mature personality with excellent leadership and interpersonal skills.
• - Ability to motivate, lead and develop multiple staff of various sizes and skill sets/backgrounds.
• - To be effective in communication with the Health Authorities and Health Care Professionals
• - Comfort and confidence presenting pharmacovigilance system related aspects and benefit risk particularly to regulators.
• - Leadership experience in managing people at a geographic distance.
• - Cultural sensitivity, patient but persuasive.
• - Excellent oral and written communication in English.

We offer

• - The probation period of 3 months and then for an indefinite period;
• - Possibilities for development on a personal and professional level in one of the leading global MedTech companies;
• - Package of benefits including Private medical care (Lux Med), Life Insurance, and Multisport card;
• - Holiday Bonus, Annual Bonus, Newborn baby Bonus;
• - Co‑financing for corrective glasses and lenses;
• - Benefit platform (300 PLN monthly);
• - PPE program with very attractive conditions available for each employee after 3 months;
• - Fully covered language courses (English or other languages according to business needs);
• - Co‑financing of holidays and an additional 2 days off from work annually;
• - Additional extra day for a birthday!
• - Recommend a friend - Referral Bonus;
• - Hybrid work model;
• - Great Warsaw office location - Powiśle!

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.