Associate, Pharmacovigilance Operations – Drug Safety

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate adverse events and assist in the determination of regulatory reporting for designated investigational products.

• Act as a liaison between internal and external stakeholders regarding adverse event reporting matters.

• Collaborate with departments including data management, clinical operations, regulatory affairs, quality, and medical affairs.

• Serve as the primary contact for inquiries, requests, and reviews related to adverse events within safety and clinical databases.

• Review incoming initial and follow-up SAE/AESI reports and generate clinically relevant queries.

• Conduct quality control checks and finalize cases entered in the Argus database.

• Supervise case processing vendors and track KPIs for vendor evaluation.

• Address issues related to safety databases and create Help Desk tickets as needed.

• Support the preparation of safety reports for regulatory bodies.

• Assist with literature reviews as necessary.

• Assess data points and generate follow-up queries within the timelines set by the protocol.

• Ensure that AE reports are comprehensive, accurate, legible, and consistently evaluated.

• Implement FDA and ICH guidelines during case assessments.

• Contribute to the coding of medical terms, procedures, and concomitant medications.

• Maintain up-to-date eTMF status for pertinent safety communications and documents.

• Produce scheduled and ad hoc safety database reports for the clinical team.

• Provide expertise in adverse events.

• Participate in and contribute to internal meetings.

• Assist with projects assigned by direct supervisors or leadership within the PV department.

• Review and develop Safety Management Plans, safety summaries, and SAE reconciliation documents.

⛳️ Requirements

• A minimum of a bachelor's degree or higher in a clinical or closely related field.

• 2-3 years of relevant experience in a biotech or pharmaceutical setting.

• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology is strongly preferred.

• Experience in post-marketing activities is desirable.

• Proficiency in the Argus safety database system is required.

• Familiarity with MedDRA and WHODrug coding is preferred.

• Experience with Veeva Vault is preferred.

• Exceptional written and verbal communication skills.

• Strong attention to detail is essential.

• Excellent organizational and prioritization abilities.

• Capability to work both independently and collaboratively in a team environment.

• Ability to manage daily operations alongside special projects in a growing organization.

• Proficiency in medical terminology is preferred.

🏝️ Benefits

• Pre-IPO equity.

• Annual bonus.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Paid time off (PTO).

• 401(k) plan.

• Life and accidental death and disability insurance.

• Parental leave benefits.

• Subsidized daily lunches and snacks at on-site locations.