Pharmacovigilance Risk Management Specialist

4 tygodni temu

Warsaw, Polska Baxter Pełny etat

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Pharmacovigilance Risk Management Specialist

Location: Warsaw

Summary:

This position is part of the Risk Management function within the GPS organization, responsible for the development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.

What you'll be doing?

Facilitate cross-functional review and approval of PV-RMPs. Respond to queries/requests from regulatory authorities regarding PV-RMPs. Independently lead project timelines associated with the preparation and submission of PV-RMPs. Represent GPS Risk Management on cross-functional teams. Collaborate with country organizations in developing and leading PV-RMPs and associated dedication activities. Assist RM manager/commitment tracking tool owner with planning and oversight of PV-RMP commitments.

Qualifications:

Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Experience with other regional/local regulations is desired. Excellent analytical and critical thinking skills. Excellent oral, written, and interpersonal communication skills, including the ability to lead cross-functional group discussions and meetings. Scientific/clinical knowledge and excellent scientific writing skills. Ability to independently lead long- and short-term project timelines and deliverables. Exposure to working relationships with regulatory authorities.

Education/Experience:

Bachelor’s degree in nursing/biologic/medical/clinical field; advanced degree and prior clinical practice experience is desired. Minimum two years’ prior pharmaceutical-proven experience in Pharmacovigilance or Medical/Clinical functions.

What we offer:

1 year fix term contract ( parental cover).

Competitive salary, annual bonuses, recognition award program.

Company culture is based on our values: collaboration, speed, courage and simplicity.

Possibilities for development on a personal and professional level in one of the top-tier global MedTech companies.

Package of benefits including Private medical care (Lux Med), Life Insurance, and Multisport card.

Bax4U - cafeteria/lunch cards (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.

Employee Stock Purchase Plan.

Great Warsaw office location - Powiśle

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in person in support of our Mission.

  • Risk Management Specialist

    3 tygodni temu

    Warsaw, Polska SIX Payment Services Pełny etat

    Risk Management Specialist Date posted 02/29/ Location Warsaw | Poland Company Worldline This is WorldlineWe are the innovators at the heart of the payments technology industry, shaping how the world pays and gets paid. The solutions our people build today power the growth of millions of businesses tomorrow. From your local coffee shop to unicorns and...

  • Risk Management Specialist

    4 tygodni temu

    Warsaw, Polska Worldline Pełny etat

    The Opportunity The risk assessment process is a part of the merchant onboarding process and merchant monitoring process and consists of evaluating and analysing a merchant account application from a risk perspective throughout the life cycle. The risk assessment includes analyzing several aspects such as: KYC, AML , merchant business model, business...

  • Risk Management Specialist with French or Dutch

    3 tygodni temu

    Warsaw, Polska SIX Payment Services Pełny etat

    Risk Management Specialist with French or Dutch Date posted 03/18/ Location Warsaw | Poland Company Worldline Risk Management SpecialistWarsaw - hybridThis is WorldlineWe are the innovators at the heart of the payments technology industry, shaping how the world pays and gets paid. The solutions our people build today power the growth of millions of...

  • Regulatory Affairs

    3 tygodni temu

    Warsaw, Polska People Sp. z o.o. Pełny etat

    Dla Naszego Klienta – międzynarodowej firmy z branży farmaceutycznej poszukujemy osoby na stanowisko:Regulatory Affairs / Pharmacovigilance SpecialistLokalizacja: Warszawa Śródmieście (praca hybrydowa)Zakres obowiązków:Działania związane z utrzymaniem pozwoleń na dopuszczenie do obrotu (MA), odpowiedziami na pytania i zobowiązania regulacyjne,...

  • Risk Management Specialist with French

    3 tygodni temu

    Warsaw, Polska Worldline Pełny etat

    The Opportunity The risk assessment process is a part of the merchant onboarding process and merchant monitoring process and consists of evaluating and analysing a merchant account application from a risk perspective throughout the life cycle. The risk assessment includes analysing several aspects such as: KYC, AML, merchant business model, business...

  • Engineer, Commodities Risk Technology

    1 tydzień temu

    Warsaw, Polska Balyasny Asset Management L.P. Pełny etat

    Role Overview The Commodities Risk Technology team builds large scale Cloud-native distributed systems to support risk modeling, risk calculation, risk market data processing, risk reporting, risk guidelines monitoring, and risk research for Commodities Risk Management front office teams across Balyasny. The team’s major clients include the Risk...

  • Application Software Risk Management

    2 dni temu

    Warsaw, Polska b2bnetwork Pełny etat

    Detailed description of work task to be carried outThe main work will be holding meetings where we need to communicate the projects goal and also guide the Application owners and providers in creating a risk with mitigations on their application in Klient risk tool.Risk Management, good communication skills. Description of knowledge and experienceGood to...

  • Director, Information Security Risk Management

    3 tygodni temu

    Warsaw, Polska IQVIA Pełny etat

    Role Location: Poland or Portugal Job Overview The successful candidate will play an integral role in developing the information security Risk Management framework for IQVIA and will manage risks identified through a variety of IT and operational audits. You will be responsible for managing the development of team members and will engage with senior...

  • Risk, Model Risk Management, Vice President, Warsaw

    4 tygodni temu

    Warsaw, Polska Goldman Sachs Pełny etat

    RISK Our Risk teams develop comprehensive processes to monitor, assess, and manage the risk of expected and unexpected events that may have an adverse impact on the firm. Risk professionals execute critical day-to-day risk management activities, lead projects, and contribute to the ongoing advancement of a robust risk management program. Effective...

  • Merchant Expertise Risk Specialist

    1 tydzień temu

    Warsaw, Polska Worldline Pełny etat

    The Opportunity As a Specialist in the Merchant Expertise Team, you are at the forefront of defining and implementing integrity risk measures, especially in the domains of scheme, AML, and KYC. You'll play a key role in drafting procedures and work Instructions, handling various onboarding and ODD escalations, and more, ensuring that the company and...

  • KYC/AML Risk Specialist

    3 tygodni temu

    Warsaw, Polska Worldline Pełny etat

    The Opportunity As a Specialist in the Merchant Expertise Team, you are at the forefront of defining and implementing integrity risk measures, especially in the domains of scheme, AML, and KYC. You'll play a key role in drafting procedures and work Instructions, handling various onboarding and ODD escalations, and more, ensuring that the company and...

  • Associate Director, Risk based Quality Management

    3 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    ABOUT ASTRAZENECA At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company...

  • Security & Risk Assessment Specialist

    3 tygodni temu

    Warsaw, Polska ITFS sp. z o.o. Pełny etat

    technologies-expected : TPRM about-project : Workplace: Kraków / Wrocław Start: ASAP Form of cooperation: B2B with ITFS (first contract for 6 months + extension possible) Rate: 120-140 PLN/h net + VAT Client: large multinational bank responsibilities : Analyzing and evaluating security controls and documentation policies (evidence) Recommending...

  • Model Risk Reporting Specialist – Model Risk Oversight

    1 tydzień temu

    Warsaw, Polska ING Pełny etat

    We are looking for you, if you: have a quantitative degree and are interested in Data Analytics, are a Risk professional with hands-on Risk Reporting experience in SAS MRM tool, Python coding or equivalent custom tools/products, have automation experience in Python/VBA have experience in quantitative analysis, report design and execution, you are...

  • Security & Risk Assessment Specialist

    1 tydzień temu

    Warsaw, Polska ITFS sp. z o.o. Pełny etat

    Expected, TPRM About the project, Workplace: Kraków / Wrocław, Start: ASAP, Form of cooperation: B2B with ITFS (first contract for 6 months + extension possible), Rate: 120-140 PLN/h net + VAT, Client: large multinational bank Your responsibilities, Analyzing and evaluating security controls and documentation policies (evidence), Recommending mitigation...

  • Chief Data Office – Data Risk Management Associate

    4 tygodni temu

    Warsaw, Polska JPMorgan Chase & Co. Pełny etat

    You are passionate about data management, enjoy implementing solutions, interested in driving data governance and policy, this role is for you. As a Chief Data Office – Data Risk Management Associate/Senior associate in the Firmwide Finance Business Architecture team (FFBA) you will be part of a high performing team of data management professionals...

  • Chief Data Office – Data Risk Management- Vice President

    4 tygodni temu

    Warsaw, Polska JPMorgan Chase & Co. Pełny etat

    You are passionate about data management, enjoy implementing solutions, interested in driving data governance and policy, this role is for you. As a Chief Data Office – Data Risk Management Vice President in the Firmwide Finance Business Architecture team (FFBA) you will be part of a high performing team of data management professionals focused on...

  • Chief Data Office – Data Risk Management Senior Associate

    4 tygodni temu

    Warsaw, Polska JPMorgan Chase & Co. Pełny etat

    You are passionate about data management, enjoy implementing solutions, interested in driving data governance and policy, this role is for you. As a Chief Data Office – Data Risk Management Senior Associatet in the Firmwide Finance Business Architecture team (FFBA) you will be part of a high performing team of data management professionals focused on...

  • Chief Data Office – Data Risk Management- Vice President

    3 tygodni temu

    Warsaw, Polska J.P. Morgan Pełny etat

    Job Description You are passionate about data management, enjoy implementing solutions, interested in driving data governance and policy,  this role is for you. As a Chief Data Office – Data Risk Management Vice President in the Firmwide Finance Business Architecture team (FFBA) you will be part of a high performing team of data management professionals...

  • Chief Data Office – Data Risk Management- Vice President

    3 tygodni temu

    Warsaw, Polska J.P. Morgan Pełny etat

    Job Description You are passionate about data management, enjoy implementing solutions, interested in driving data governance and policy,  this role is for you. As a Chief Data Office – Data Risk Management Vice President in the Firmwide Finance Business Architecture team (FFBA) you will be part of a high performing team of data management professionals...