200+ applicantsPosted by Agency
Advanced Recruiting Partners · 3 days ago
Product Safety Specialist
United States
Contract
Remote
Mid Level
3+ years exp
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Responsibilities
Ensure compliance with international regulations and guidelines for drug safety monitoring.
Stay updated with changes in pharmacovigilance legislation and adapt processes accordingly.
Manage the entire lifecycle of safety cases, from initial reporting to resolution.
Perform thorough documentation of adverse event reports, ensuring completeness and accuracy.
Monitor and follow up on reported safety cases to ensure timely and appropriate action.
Utilize industry-standard safety databases for case management and reporting.
Apply MedDRA and WHO Drug coding systems to ensure accurate and consistent data entry and analysis.
Maintain the integrity of safety data through rigorous data management practices.
Prepare for regulatory inspections by organizing and providing comprehensive documentation.
Respond to inquiries from health authorities and auditors promptly and accurately.
Collaborate with internal teams to ensure readiness for inspections and audits.
Demonstrate excellent written and verbal communication skills to convey complex safety information.
Work closely with cross-functional teams, including clinical, regulatory, and quality assurance departments.
Provide training and guidance to team members on pharmacovigilance practices and regulatory requirements.
Qualification
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Required
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; advanced degree preferred.
Proven experience in pharmacovigilance or a related field, with a strong understanding of global regulatory requirements.
Proficiency in safety database applications and MedDRA/WHO Drug coding.
Experience supporting regulatory inspections and audits.
Excellent written and verbal communication skills.
Strong organizational and time management skills, with the ability to manage multiple priorities.
Preferred
Certification in pharmacovigilance or related areas.
Familiarity with electronic submission standards and regulatory reporting tools.
Experience working in a global or multi-national pharmaceutical company.
Company
Advanced Recruiting Partners
Advanced Recruiting Partners (ARP) is a premium staffing agency dedicated to serving companies in the biopharmaceutical and life science industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Christopher Young
COO
Company data provided by crunchbase
