Planet Pharma · 12 hours ago
Compliance Specialist (Global Regulatory Affairs and Drug Safety)
Valley Forge, PA
Full-time
Onsite
Entry Level
$35/hr - $45/hr
1+ years expPlanet Pharma is a company focused on global regulatory affairs and drug safety, and they are seeking a Compliance Specialist contractor. This role involves executing regulatory and pharmacovigilance compliance activities, supporting investigations, and managing quality assurance processes to ensure adherence to relevant regulations and procedures.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Bachelors degree in business or life sciences required
Preferred
Lean Sigma certification, or equivalent certification, preferred but not required
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase