- You will plan, conduct, report and follow up on quality audits within the PV regulated areas.
- You will develop and improve the PV audit strategy and drive the PV audit plan in collaboration with very senior QA PV colleagues.
- You will develop tools to improve and facilitate the audit processes.
- Mentoring on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across QA GCP & PV.
- You will lead PV inspections readiness activities as well as PV partner audits too.
- coordinate and lead GCP inspection readiness activities for FDA, EMA and PMDA inspections
- You will participate in inspections and audits performed by partners.
- You will represent QA in the PV and Medical Affairs Process Expert Group
- Participate or drive the development, maintaining and improving the Genmab QMS with focus on PV requirements.
- Develop and execute internal training of PV requirements and deliver PV advisory expertise within the company and to external vendors.
- MSc in Natural Science or similar and at least 6 years of profound experience within auditing of Pharmacovigilance activities
- Experienced Lead Auditor within PV preferable in-death knowledge related to outsourced safety processes and internal safety processes. It is great if you are also an experienced GCP auditor.
- Proficiency in the use and understanding of Veeva Vault QMS will be an advantage.
- Experience with the due diligence process and qualification of new vendors or services
- Considered as Domain Expert within PV by peers and has a strong interest and ability to educate others.
- Strong analytical skills with eye for the detail and still with the ability to lift it into a tactic and strategic context.
- Strive in a setting with multiple complex tasks and shifting priorities.
- Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
-
Senior Manager, QA GCP/PV
Fundet i: Talent NL C2 - for 4 dage siden
Genmab Copenhagen, Danmark FuldtidThe Role · & Department Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab's knock-your-socks-off "KYSO" antibody medicines will transform the lives of people with ca ...
-
Associate Director, PV Alliance Management
Fundet i: Talent DK C2 - for 6 dage siden
Ascendis Pharma Hellerup, Danmark FuldtidAre you passionate about pharmacovigilance and establishing relationships with key partners? Do you have experience in a drug safety environment with pharmacovigilance operational responsibilities and negotiating contracts with strategic partners? · If so, now is your chance to j ...
-
Director, Global Drug Safety
Fundet i: Talent NL C2 - for 4 dage siden
Genmab Copenhagen, Danmark FuldtidAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Director, Team Leader, External Data Quality Management, Clinical Data Management
Fundet i: Talent NL C2 - for 3 dage siden
Genmab Copenhagen, Danmark FuldtidThe Role · The Director, Team Leader, External Data Quality Management, Clinical Data Management, at Genmab is operationally responsible for the oversight of External Data Quality Management activities related to effective planning and timely delivery of complete, high-quality, a ...
-
Associate Director, Solutions Architecture
Fundet i: Talent NL C2 - for 4 dage siden
Genmab Copenhagen, Danmark FuldtidThe Role · At Genmab, AI and Digital Technologies are being developed, implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products as part of our IT & Digital Team and become a key player ...
-
Manager, Clinical Trial Planning
Fundet i: Whatjobs DK C2 - for 1 dag siden
Genmab Copenhagen, DanmarkAt Genmab, we're committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Quality Specialist
Fundet i: beBee S2 DK - for 3 dage siden
Ortolan København, Danmark FuldtidQuality Specialist · Copenhagen, Denmark (hybrid: 3 days office, 2 days home) · Salary: Competitive + Benefits + Bonus · If you are an agile, committed, and innovative pharmaceutical quality specialist, then we want to hear from you · Join us to help improve peoples' lives an ...
-
Manager, Clinical Trial Planning
Fundet i: Appcast US A2 - for 1 dag siden
Genmab Copenhagen, Danmark FuldtidAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Associate Director, Global Clinical Drug Supply
Fundet i: Talent DK C2 - for 4 dage siden
Genmab Copenhagen, Danmark FuldtidThe Role · & DepartmentGenmab is searching for an experienced and energized Associate Director to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement. · Ha ...
-
Associate Director, Medical Writing
Fundet i: Talent DK C2 - for 5 dage siden
Genmab Copenhagen, Danmark FuldtidAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Clinical Drug Supply Manager
Fundet i: Talent DK C2 - for 2 dage siden
Genmab Copenhagen, Danmark FuldtidThe Role · & DepartmentGenmab is searching for an experienced Clinical Drug Supply Manager to be part of Global Clinical Drug Supply Operations in Copenhagen, DK or Princeton, NJ in commuting distance to our office locations to work according to our hybrid work arrangement. · Mov ...
-
Sustainability & Energy Simulations Specialist
Fundet i: beBee S2 DK - for 1 dag siden
BIG - Bjarke Ingels Group Valby, Danmark FuldtidJob Area: · Sustainability · Location: · 45 Main Street, 9th Floor · 11201 Brooklyn, NY · United States · New York · Join BIG · BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhag ...
-
Principal Pharmacovigilance Specialist
Fundet i: Talent DK C2 - for 2 dage siden
Novo Nordisk Søborg, DanmarkAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stak ...
-
Principal Pharmacovigilance Specialist
Fundet i: Talent DK C2 - for 2 dage siden
Novo Nordisk A/S Søborg, DanmarkAre you ready to assume a key coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and co-operating with many different stak ...
-
Clinical Trial Manager
Fundet i: Talent DK C2 - for 6 dage siden
Ascendis Pharma Hellerup, Danmark FuldtidAre you passionate about clinical trial management and do you want to take part in paving the way in a fast-growing and innovative biopharmaceutical company? Then this is a great opportunity for you..... · The role · As Clinical Trial Manager, you will be responsible for the effe ...
-
Head of Site Management
Fundet i: beBee S2 DK - for 10 timer siden
Nordic Solar A/S Hellerup, Danmark FuldtidAbout the position · We are seeking a highly motivated and experienced individual to join our EPC team as Head of Site Management. In this role, you will be responsible for overseeing on-site and country-specific operational control, stakeholder management, and ensuring the seaml ...
-
Senior Specialist Clinical Data Manager
Fundet i: Talent DK C2 - for 5 dage siden
Ascendis Pharma Hellerup, Danmark FuldtidAre you passionate about Clinical Data Management? Do you have solid experience leading clinical data management activities for complex studies? Are you familiar with all clinical data management activities from start-up, conduct to closure? · If so, now is your chance to join As ...
-
Senior Clinical Trial Data Manager
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Søborg, DanmarkAre you experienced in clinical trial data management? Are you ready for the next step in your career? We are looking for a Senior Clinical Trial Data Manager to join our global Data Management & Centralised Data Review (DMCDR) team at Novo Nordisk. · If you are passionate about ...
-
Senior Project Manager
Fundet i: Talent DK C2 - for 5 dage siden
DSV Hedehusene, DanmarkTime Type: · Full Time Would you like to join a global company at the forefront of reducing the carbon footprint within the transport industry? And do you want to run large capital energy projects which make up one of our strategic pillars? · Join us to work closely with other pr ...
-
Technical Director of Data Engineering
Fundet i: beBee S2 DK - for 3 dage siden
Capax Recruitment ApS Hedehusene, Danmark FuldtidDenne stilling er hos DSV · DSV er en dynamisk arbejdsplads, der fremhæver inklusion og diversitet som kerneværdier. De driver deres forretning med integritet, respekt for forskellige kulturer samt værdighed og rettigheder for individer. Som en del af DSV bliver du en del af en a ...
Associate Director, QA GCP/PV - Copenhagen, Danmark - Genmab
Beskrivelse
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
QA PV Associate Director
Do you want to safeguard patients and ensure quality compliance in all aspects within Pharmacovigilance? – Then take this great career opportunity
Are you inspired by working in a company with ambitious goals, exciting development programs, and highly enthusiastic colleagues? Our vision is that by , Genmab's knock-your-socks-off "KYSO" antibody medicines are transforming the lives of people with cancer and other serious diseases.
We are looking for a highly motivated QA PV Associate Director with at least 6 years of experience in auditing PV activities. You are already an experienced PV lead auditor with the capabilities to train other auditors within Pharmacovigilance.
As QA Associate Director you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to Pharmacovigilance activities. You will have strong analytical skills, high quality standards, detail-oriented with the ability to apply in into a strategic context that enables you to identify solutions within the agreed deadlines.
You will be working in a global team with QA colleagues located in the US, the Netherlands, in Japan as well as in Denmark. Furthermore, you will be part of a strong cross-functional collaboration across the company.
Key responsibilities include:
Requirements:
Moreover, you meet the following personal requirements:
This role is located in Denmark. It is the expectation that the role includes on-site presence combined with the option to work remotely a couple of days per week on average.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
