60 Pharmacovigilance Operations Lead Jobs in Waltham, MA
SORT BY
D
E
H
I
H
B
B
A
C
F
F
N
F
A
F
B
A
P
V
P
A
T
Z
Z
B
Pharmacovigilance Operations Lead
$113k-133k (estimate)
Full Time
1 Month Ago
Innoviva Specialty Therapeutics is Hiring a Pharmacovigilance Operations Lead Near Waltham, MA
Position TitlePharmacovigilance Operations Lead (contractor)DepartmentPharmacovigilance Reports toHead of PharmacovigilanceLocationHybridDetailsExemptDirect ReportsnoneCompany Overview:Innoviva Specialty Therapeutics is dedicated to bringing innovative therapies for patients in critical care and infectious disease. We endeavor to address unmet needs so physicians can deliver the best treatment for each patient. Innoviva currently has two marketed product medicines – GIAPREZA (angiotensin II) a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock and XERAVA (eravacycline) an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI). In addition, Xacduro (sulbactam for injection; durlobactam for injection) co-packaged for intravenous use was approved in May of 2023 as the first pathogen-targeted antibacterial approved by the US FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Innoviva Specialty Therapeutics is uniquely positioned to advancing solutions for the most critical and urgent infections identified by the world's leading public health organizations.
Responsibilities:
Responsibilities:
- Provide day-to-day oversight of PV vendor activities including reviewing case management, submissions, and literature review for clinical and post marketing products
- Generate/review metrics of case quality and compliance and monitor for trends or possible improvements.
- Ensuring proper filing of emails and reports into document repository
- Support weekly and monthly reconciliations and follow-up to ensure resolution.
- Provide safety operations support on ongoing clinical trials.
- Support aggregate report project management including collection of information and quality review.
- Participate in the review and maintenance of PV SOPs, vendor/study plans, and guidance documents to ensure compliance.
- Bachelor's degree or higher in a healthcare related field (nursing, pharmacy, PA, MPH, etc.)
- 3 years in post marketing and clinical Pharmacovigilance / Drug Safety with 5 years of experience in the pharmaceutical industry
- Experience with managing and providing oversight of a PV vendor.
- Experience with Veeva Vault, Veeva RIM, and Argus safety database preferred.
- Knowledge of GCP/GVPs, FDA regulations and ICH guidelines
- Strong interpersonal and communication skills; proactive approach. Able to work independently.
- Detail-oriented with good organizational, prioritization, and time management skills. Must be able to work on multiple projects simultaneously.
Job Summary
JOB TYPE
Full Time
SALARY
$113k-133k (estimate)
POST DATE
05/27/2024
EXPIRATION DATE
07/08/2024
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
