drjobs Senior PV Specialist

Senior PV Specialist

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1 Vacancy
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Job Location drjobs

Raleigh, NC - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title: Senior PV Specialist (legal/medical review)

Job Location: Raleigh NC USA

Job Location Type: Remote

Job Contract Type: Fulltime

Job Seniority Level: MidSenior level

For the past 20 years ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech med device and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization) ProPharma partners with its clients through an advisebuilrate model across the complete product lifecycle. With deep domain expertise in regulatory sciences clinical research solutions quality & compliance pharmacovigilance medical information and R&D technology ProPharma offers an endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners’ most highprofile drug and device programs.

The Senior Pharmacovigilance (PV) Specialist Case Processing is primarily responsible for peer review of cases within the Case Processing team. The Senior PV Specialist performs initial caselevel assessment of expectedness confirms seriousness performs quality check of individual case safety reports composes accurate and thorough medical narratives and generates queries for missing or unclear information. The Senior PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines Working Practices SOPs and applicable safety regulations. The Senior PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally.

Essential Functions

  • Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed) including coding using MedDRA determining seriousness and expectedness at the event and case level.
  • Perform case follow up activities such as identification of information to be collected during followup.
  • Creating and reviewing case narratives.
  • Providing client notifications as required for case management.
  • Supporting and contributing to the development of training materials and training delivery.
  • Highlight areas of concern/discrepancies to the Principal PV Specialist Case Processing and/or Manager Case Processing when related to ICSRs.
  • Acquire and maintain an uptodate knowledge of global safety regulations for medicines.
  • Peer reviews of cases for quality consistency and accuracy.
  • Provide oversight and direction of PV deliverables as a PV subject matter expert as needed.
  • Perform Health Care Professional (HCP) review (as required).
  • Mentors and trains less experienced staff.
  • Other duties as assigned.

Necessary Skills And Abilities

  • Strong verbal written and interpersonal communication skills.
  • Intermediate project management skills.
  • High level of accuracy and attention to detail.
  • Ability to identify and resolve problems in a timely manner.
  • Able to work independently and collaboratively in a multidisciplinary team.
  • Excellent organization and prioritization skills; able to multitask.
  • Intermediate knowledge of Pharmacovigilance.
  • Working knowledge of PV Systems such as Oracle Argus Safety ARISg or other safety databases.
  • Legal/Medical case review experience preferred.

Educational Requirements

  • Required: a Bachelor's degree in life sciences.
  • Preferred: an advanced degree RN RPh PharmD or equivalent.

Experience Requirements

Three years of related work experience.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity equity and inclusion. Employees are encouraged to unleash their innovative collaborative and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please no phone calls or emails to anyone regarding this posting.***



Lifelancer https://lifelancer is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.

For more details and to find similar roles please check out the below Lifelancer link.

https://lifelancer/jobs/view/b71f416db5473f6732600af5440014c9

Employment Type

Full Time

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