Job Information
Actalent Pharmacovigilance Manager in Morristown, New Jersey
Description:
o Ensure fulfilment of company obligations towards regulatory authorities US, by timely planning, preparation and submission of applicable documentation.
o Ensure adequate quality of submitted documentation by performing timely review.
o Ensure adequate tracking of activity.
Main Responsibilities
Clinical Trials
o Reviews SAEs, the safety sections of study protocols, ICF, SMP, study reports (CS), IB, and DSURs.
o SAE reconciliation -Gives input, as requested, in selecting the reference safety information for clinical studies and informs Clinical Development Department (CDD) of any safety issues that may potentially impact the selected reference safety information, during study conduct.
o Acts as contact person with CDD for any safety issues pertaining to clinical trials.
ICSRs
o Ensure that all ICSRs received or collected, from all sources, are entered in the Safety Database.
Ensure that all ICSRs that need to be expedited are handled and sent in a timely manner.
o Medical review of ICSRs. MedDRA coding, Expectedness assessment. Causality Assessment and Company Comment. MedWatch and CIOMS review.
• Overview of compliance in relation to the quality, completeness and timeliness of ICSRs.
Aggregate reports
. Preparation of yearly schedule of periodic reports. Ensure that all pharmacovigilance documents are prepared in time and are quality controlled.
Overview of compliance in relation to the quality, completeness and timeliness of aggregate reports.
Signal Detection activities
o Review of signal detection reports.
o Keep tracking of allocated INNs signal detection activities.
o Actively participate in signal assessment meetings.
o Make recommendations based on the conclusions of the signal detection activities.
Risk Management Plans/REMS Program
o Review Risk Management Plans.
o Review REMS Documents.
o Maintain Risk Management Plans and REMS.
o Participate in the implementation of risk minimization measures as provided in the Risk
o Management Plans/REMS.
Documentation activity
o Maintenance of trackers
o Receive information on new marketing authorizations, launches, withdrawals, changes in MA holders, safety related changes
o Archiving
Overview of all processes and procedures that are in place in the pharmacovigilance department
o SOP preparation and maintenance.
o Training on all appropriate SOPs.
Review of potential impact of legislation findings on PV processes.
Review of SDEA agreements (and or its representatives) and Partners.
Review and conduct reconciliation efforts with all partners
o Review KPIs
o PV vendor oversight
o Support any deviations and CAPA management, including collaboration with SMEs to collect and track the receipt of objective evidence to support Deviations & CAPAs
Regulatory Authorities and partners (both internal and external) interactions
o Reporting.
o Ensure that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks is answered fully and promptly.
o Provision to the competent authorities of important information regarding the benefit-risk assessment for products.
o Participate in the implementation of the corrective actions related to pharmacovigilance inspections and audits.
Review and maintenance of RSI
o Evaluate the need for RSI update
o Review of USPI and supportive documentation.
o Review of Medical Information requests.
o Review of relevant Medical information requests.
Training of new PV employees
o Prepare training plan of new employee.
o Ensure training and mentorship
Required Education
• Bachelor's degree or equivalent in Human Medicine or Pharmacy.
Required Experience:
• A minimum of 3 year's experience in similar position or a minimum experience of 6 years in pharmaceutical industry/CRO
Required Skills
o English language: advance level (both speaking and writing, good understanding of medical
English terms is a must).
o Computer skills: very good knowledge of MS Office tools (MS Excel knowledge is a must).
Communication skills: highly flexible individual with very good communication skills which can enable system improvement
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.