Skip navigation
Unable to save this job. Please try again later.

{msg}

Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Boston, MA
  • Yannick Dada

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest Operations Manager jobs in Boston, MA delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
• 
8 to 15 characters
• 
1 uppercase letter
• 
1 number or symbol
• 
1 lowercase letter
Cancel
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!

Manager, Pharmacovigilance (PV) Operations

ProClinical • Boston, MA

Posted 2 months ago

Job Snapshot

Full-Time
Highly Competitive Salary
Pharmaceutical
Science

Job Description

ProClinical, in support of our client, are seeking an individual to fill the role of Manager of Pharmacovigilance (PV) Operations, based in Boston, MA. The successful candidate will be a creative, resourceful, and integrative thinker who will work on and processes that ensure the strategies of the department are executed within global safety legislation and requirements.

Responsibilities

  • Review and execute PV Operations safety data collection strategy.
  • Provide oversight and review of vendor case processing activities.
  • Participate in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency.
  • Provide knowledge into Clinical and Post Marketing teams on the needs and timelines of organized data collection.
  • Participate in the creation and dissemination of appropriate safety reporting language.
  • Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs.
  • Participate in projects that develop and support strong cross-functional relationships and communication.
  • Maintain knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods
  • Contribute to projects which involve the implementation of new processes and methods within and across Global Patient Safety.
  • Undertake activities necessary to maintain a state of inspection readiness
  • Provide sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
  • Participate in the quality review of SAEs and SUSARs following data entry by vendor.
  • Represent Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
  • Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.

Skills and Qualifications

  • BA in a health care related profession or life sciences required. MA in same preferred.
  • 5-7 years of Drug Safety and Pharmacovigilance experience and vendor management experience.
  • Knowledge of FDA, ICH, EU regulations and requirements for Pharmacovigilance.
  • Experience using ARISg, Argus or other Safety Database applications required.
  • Strong written, verbal, and interpersonal communication skills.
  • Strong proficiency in Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 646-741-8433 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-YD1

Job ID: DS.YD.23040
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
CAREERBUILDER TIP
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

More Jobs at ProClinical

View All Similar Jobs View All Similar Jobs