Safety and Pharmacovigilance Specialist I job at Piper Companies in Bethesda, MD

Title: Safety & Pharmacovigilance Specialist I

Job Id:
161090

Job Category:

Job Location:
bethesda, Maryland

Security Clearance:
No Clearance

Business Unit:
Piper Companies

Division:
Piper Enterprise Solutions

Position Owner:
Madeline Remington

Job Description:

Piper Companies is seeking a Safety & Pharmacovigilance (S&P) Specialist to join a dynamic team in Bethesda, MD. This role is ideal for professionals with a strong background in clinical research and drug safety who are passionate about ensuring regulatory compliance and supporting the development of investigational and marketed drugs. This is a hybrid position requiring two days on site in Bethesda, MD and 3 days remote. MASTER'S/MEDICAL DEGREE REQUIRED (foreign MD accepted).

Responsibilities for the Safety & Pharmacovigilance (S&P) Specialist Includes:

Ensure compliance with TRI SOPs, FDA, WHO, and global regulations for adverse event reporting.
Develop and manage uniform, timely processing of adverse event reports.
Provide medical evaluation of adverse event reports.
Support clinical research activities including reporting, collecting, and sharing adverse event data.
Maintain and update toxicity summary tables for investigational agents.
Conduct literature searches related to drug safety and efficacy.
Analyze and process adverse events; reconcile serious adverse events.
Prepare IND safety reports for FDA submission and conduct safety data analysis.
Provide clinical trial site support and manage safety communications.
Assist in preparing NDA safety updates, IND safety reports, investigator communications, product labeling, and other regulatory documents.
Review experimental protocols and informed consent documents; prepare and edit safety-related presentations.
May review experimental protocols and informed consent documents; and prepare, review, and edit presentations regarding safety issues.

Qualifications for the Safety & Pharmacovigilance (S&P) Specialist Includes:

Master’s/Medical Degree required.
Minimum 2 years of experience in academic, pharmaceutical, or biotech industry.
Strong knowledge of GCP and ICH guidelines; clinical trial experience essential.
Familiarity with safety databases and MedDRA coding preferred.
Experience leading clinical and cross-functional teams is a plus.
Excellent oral, written, presentation, and computer skills.

Compensation for the Safety & Pharmacovigilance (S&P) Specialist Includes:

Salary Range: $80,000.00 – $90,000.00 annually, depending on experience and certifications
Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401K through ADP

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Keywords:

Safety & Pharmacovigilance, Drug Safety, Clinical Research, Adverse Event Reporting, Serious Adverse Events (SAE), Safety Data Analysis, Toxicity Summary Tables, FDA Regulations, IND Safety Reports, NDA Safety Updates, Global Safety Reporting, WHO Guidelines, TRI SOPs, ICH Guidelines, GCP Compliance, Medical Evaluation, MedDRA Coding, Safety Databases, Clinical Trial Support, Regulatory Compliance, Pharmacovigilance Operations, Safety Communications, Literature Search, Medical Writing, Regulatory Submissions, Investigator Communications, Product Labeling, Cross‑Functional Collaboration, Clinical Operations, Hybrid Role, Bethesda MD, Master’s Degree Required, Medical Degree Required, Biotech Industry, Pharmaceutical Industry, Data Management, Safety Case Processing, Protocol Review, Informed Consent Review, Health Communications, Presentation Development, Scientific Documentation, Adverse Event Processing, Remote/Onsite Hybrid, Clinical Monitoring Support, CRO Environment.

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