Pharmacovigilance Operations Lead
1 month ago
Position Title
Pharmacovigilance Operations Lead (contractor)
Department
Pharmacovigilance
Reports to
Head of Pharmacovigilance
Location
Hybrid
Details
Exempt
Direct Reports
none
Company 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:
* 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.
Requirements:
* 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 safety databases, EDC systems, and document control systems required.
* 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.
-
Vice President, Pharmacovigilance
1 month ago
Waltham, United States Viridian Therapeutics Inc. Full timeDescription At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Chief...
-
Vice President, Pharmacovigilance
3 weeks ago
Waltham, Massachusetts, United States Viridian Therapeutics, Inc Full timeAt Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.Reporting to the Chief Medical Officer,...
-
Waltham, United States Morphic Holding, Inc. Full timeDescription About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...
-
Medical Director, Pharmacovigilance
1 month ago
Waltham, United States Deciphera Full timeCompany Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled...
-
Waltham, United States BioSpace Full timeJob DetailsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...
-
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Waltham, United States BioSpace, Inc. Full timeJob Details Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...
-
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Waltham, United States MURAL ONCOLOGY PLC Full timeThe Mural team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated individual to join our team. Overview The Executive Medical Director serves as the functional head of DSPV, and is accountable for the management, mentoring and development of assigned benefit-risk management staff as well...
-
Waltham, United States Deciphera Full timeCompany Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled...
-
Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
-
SVP, Head of Clinical Development
1 month ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
SVP, Head of Clinical Development
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics, Inc. Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
SVP, Head of Clinical Development
1 month ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
SVP, Head of Clinical Development
1 month ago
Waltham, United States BioSpace Full timeJob DetailsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...
-
Operations Lead
1 month ago
Waltham, United States HCLTech Full timeJob Title - Operations Lead Job Locations - Waltham, MA (Onsite) Job type – Fulltime permanent Roles and Responsibilities Work with the team to assist with resolving the daily operational issues primarily related to Waltham site and for Global sites as on when required. Responsible for handling the escalations from various IT Application owners and...
-
Senior Quality Assurance Manager
1 month ago
Waltham, United States Planet Pharma Full timeSr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply &...
-
Sr. Manager GCP quality Assurance
1 month ago
Waltham, United States Planet Pharma Full timeJob Description: Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations,...
-
Senior Quality Assurance Manager
3 weeks ago
Waltham, United States Planet Pharma Full timeSr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply &...
-
Operations Lead
1 month ago
Waltham, United States HCLTech Full timeJob Title - Operations LeadJob Locations - Waltham, MA (Onsite)Job type – Fulltime permanentRoles and ResponsibilitiesWork with the team to assist with resolving the daily operational issues primarily related to Waltham site and for Global sites as on when required.Responsible for handling the escalations from various IT Application owners and assisting...
