ZipRecruiter
Associate Director, Global Drug Safety & PV Scientist
ZipRecruiter, Plainsboro, New Jersey, United States,
Job Description
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.
Genmab is on an ambitious growth path and to support this growth Genmab is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton.
As an Associate Director of Drug Safety and Pharmacovigilance Scientist, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab’s four sites. You will be part of a highly skilled and international team. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.
Responsibilities
Perform safety review of Adverse Event reports for Genmab products
Perform ongoing surveillance (including signal
detection/evaluation)
of Genmab clinical trials and post marketing safety data
Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues
Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs
You will also be contributing to the development ofother documentation such as: Investigator’s Brochures, and Subject Informed Consent
Contribute to HA requests and review key submission documents
Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally
Contribute to the planning and conduct of Safety Committee activities and DMC’s
Conduct safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary
Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
Contribute to the development and optimization of new tools and process
Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products
Support review of Safety Data Exchange Agreements with partners as required
Collaborate with external experts and partners
Perform ongoing surveillance of new and updated
regulations/guidelines
and assess the impact on drug safety processes at Genmab
Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections
Participate in audit and inspection activities as required
Other duties as assigned
Requirements
Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
Experience within the field of oncology is
and/or first human trials
Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
Experience with use of safety databases, preferably Argus Safety Database
Documented experience from overseeing multiple trials with safety inputs at the Global level
International experience from a similar role with internal and external stakeholders
Excellent communication skills in English both written and spoken
Moreover, you meet the following personal requirements:
Strong communicator and good at building professional relations with collaborators and business partners.
You are proactive and able to prioritize work in a fast paced and changing environment
You are result-and goal-oriented and committed to contributing to the overall success of Genmab
Other
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture, and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace
across social, educational, cultural, ,
and
lines is a prerequisite for the continued success of the company. We are committed to
at all levels of the company and strive to recruit employees with the right skills and competences, regardless of , , , etc.
For US based candidates, the proposed salary band for this position is as follows:
$142,500.00---$237,500.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
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
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.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next- antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next- immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to , equity, and
We are committed to fostering workplace
at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their , , ,
(including ,
, and ),
, , , or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
https://www.genmab.com/privacy .
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
#J-18808-Ljbffr
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.
Genmab is on an ambitious growth path and to support this growth Genmab is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton.
As an Associate Director of Drug Safety and Pharmacovigilance Scientist, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab’s four sites. You will be part of a highly skilled and international team. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.
Responsibilities
Perform safety review of Adverse Event reports for Genmab products
Perform ongoing surveillance (including signal
detection/evaluation)
of Genmab clinical trials and post marketing safety data
Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues
Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs
You will also be contributing to the development ofother documentation such as: Investigator’s Brochures, and Subject Informed Consent
Contribute to HA requests and review key submission documents
Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally
Contribute to the planning and conduct of Safety Committee activities and DMC’s
Conduct safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary
Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
Contribute to the development and optimization of new tools and process
Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products
Support review of Safety Data Exchange Agreements with partners as required
Collaborate with external experts and partners
Perform ongoing surveillance of new and updated
regulations/guidelines
and assess the impact on drug safety processes at Genmab
Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections
Participate in audit and inspection activities as required
Other duties as assigned
Requirements
Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
Experience within the field of oncology is
and/or first human trials
Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
Experience with use of safety databases, preferably Argus Safety Database
Documented experience from overseeing multiple trials with safety inputs at the Global level
International experience from a similar role with internal and external stakeholders
Excellent communication skills in English both written and spoken
Moreover, you meet the following personal requirements:
Strong communicator and good at building professional relations with collaborators and business partners.
You are proactive and able to prioritize work in a fast paced and changing environment
You are result-and goal-oriented and committed to contributing to the overall success of Genmab
Other
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture, and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace
across social, educational, cultural, ,
and
lines is a prerequisite for the continued success of the company. We are committed to
at all levels of the company and strive to recruit employees with the right skills and competences, regardless of , , , etc.
For US based candidates, the proposed salary band for this position is as follows:
$142,500.00---$237,500.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
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
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.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next- antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next- immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to , equity, and
We are committed to fostering workplace
at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their , , ,
(including ,
, and ),
, , , or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
https://www.genmab.com/privacy .
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
#J-18808-Ljbffr