This role works in the PV Compliance (PVC) team within the Global Pharmacovigilance and Labelling department. The role will report to the Associate Director, PV Quality & Compliance and is responsible for performing administrative compliance activities across different datasets that have a pharmacovigilance or patient safety touchpoint. Dataset examples include but are not limited to, individual case safety report (ICSR) data, risk evaluation mitigation strategy data, regulatory information management data. This role will reconcile compliance-related investigations on ICSRs to ensure data integrity and track action items.
Additional responsibilities may include maintenance of pharmacovigilance compliance activities and support with metrics.
location: Telecommute
job type: Contract
salary: $40 - 46 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Support investigations, development of corrective and preventative action (CAPA) and effective measures for Regulatory and PV related change controls, deviations, audits and inspections.
- Support GRADS Regulatory and/or Labeling sub-functions to enhance compliance activities with a focus on inspection readiness.
- Perform quality review of assigned aggregate reports (PSUR, PADER, REMS Assessment Report, etc).
- Support the management of Regulatory and Pharmacovigilance issues, deviations, CAPA development, and change control management.
- Collaborate with GRADS Compliance team members in executing global Regulatory and PV compliance activities.
- Identify and escalate critical quality issues to senior GRADS Compliance management.
- Support (as determined by line management) Regulatory and PV process improvements including authoring/updating controlled procedures as it relates to compliance activities.
- Assists with inspection related activities, (pre-, peri- and post-inspection).
- Remain current with global regulatory affairs, labelling and PV regulations and requirements, evaluate legislative changes affecting Regulatory, Labeling and PV, and develop strategies to support patient safety.
- Monitor the PV Compliance mailbox to ensure timely actioning of communications.
qualifications:
Required Knowledge, Skills, and Abilities
- Minimum 1 year business, pharmaceutical, or biotechnology industry experience
- Can apply base level quality control technical concepts and skills
- Developing written and verbal communications skills
- Ability to work in a fast-paced environment
- Individual contributor with oversight from line manager
- Ability to work across geographical boundaries
- Disciplined, detail oriented, and good time management skills
- Bachelor's degree in business or life sciences required
- Lean Sigma certification, or equivalent certification, preferred but not required
skills: Pharmacovigilance, MS-WORD, MS-EXCEL, Drug Safety, PV CAPA Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
