Director, Pharmacovigilance Not right for you? We've got others

Salary:
Confidential
Location:
Parsippany, NJ
Posted:
July 28th 2021
Relocation Assistance:
Available
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be a part of a team that is passionate and dedicated to saving lives threatened by the
global public health crisis of bacterial infections, We strive to offer a dynamic work environment in which innovation, teamwork, knowledge and flexibility are valued.
Our novel antibiotics portfolio has the unique ability to provide providers and patients with a range
of solutions that can meet the tremendous need for treating serious infections. Our portfolio also
encourages the use of our products at various call points within the hospital or account ecosystem,
including Long Term Care Hospitals and various types of infusion centers. 
We are actively seeking to hire an experienced GPV Surveillance Scientist to lead GPV activities
overseeing current products and potentially new compounds globally. This is an exceptional opportunity
to both bring your current expertise and broaden your knowledge and responsibilities in a meaningful
and valuable fashion. The Director’s responsibilities range beyond traditional GPV to include significant
areas of Safety as it relates to drug development, and Quality Management. This is truly a growth
opportunity working with a small team that will expand as products are added to the portfolio. 
backed by a leading private equity company, dedicated to creating a sector leader in the ID space with a focus upon critical care within hospital settings.
Duties and responsibilities
 Support the Global Safety Officer in leading cross‐functional Safety Management Team (SMT) and
ensuring appropriate and timely review of safety information including trending analysis related to
product complaints, managing the safety profile of assigned products, evaluating the safety
information, performing signal detection and prioritization, and driving signal management
including risk communications, safety actions and tracking/documentation
 Maintain knowledge of safety environment/regulations, scientific literature, and competitor
products’ safety profiles
 Manage the preparation of periodic aggregate safety reports throughout the lifecycle of Melinta
drugs, Risk Management Plans, relevant sections of safety reference/regulatory documents, and
safety inquiries
 Provide PV input into safety documents and relevant sections of regulatory documents such as
clinical study reports, protocols, safety data reconciliation, safety analyses, expert statements,
submission dossiers, and health authority responses
www.melinta.com
 Support PV operational and process improvement activities within GPV, e.g. data handling
conventions, signal detection and management, safety analyses, safety data exchange agreements
with a focus on establishing safety standards, consistency across procedures, and safety data quality
 Support business development activities, regulatory authority inspections, training, product recalls,
and projects, as needed, and ensure PV/regulatory compliance with company standards and PV
Agreements
 Support and lead as needed PV Operations for processes, standards, compliance, vendor
management & PV Agreements
 Support production of compliant, quality‐driven, safety deliverables for assigned products
throughout the lifecycle
 Ensure PV compliance with health authority requirements
 Support optimal signal detection and risk management activities to ensure patient safety
 Ensure partners outside of the US have all safety information per their data exchange agreements
and facilitate review and input into their safety documents (PSUR, DSUR, PBRER)
 Support corporate initiatives and priorities to achieve efficiency gains and maintain compliance
while also putting in steps to ensure patient safety and inspection readiness
Qualifications
 Preferred five (5) years of Drug Safety/Pharmacovigilance experience, including both investigational
and marketed products
 Deep knowledge of pharmacovigilance science, operations, and regulations including knowledge of
US, ICH and EU PV regulations
 Knowledge of drug development process, including experience with safety handling in clinical trials
and post marketing
 Excellent communication skills and the ability to work with cross‐functional, multi‐cultural teams
 Experience in working with safety databases and preparation of safety reports
Education
Minimum Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field
Position Type / Expected Hours of Work
Full Time
Travel
Travel as required

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