Safety Scientist

Mindlance; Whitpain Township (PA); On-site; USD 55,000 - 83,000; Full time

Job summary

A national recruiting company is seeking qualified individuals with a Registered Nurse, Pharmacist, or related degree. Responsibilities include preparing adverse event reporting plans, ensuring compliance with regulatory documents, and assisting with pharmacovigilance processes. Candidates should have good communication and organizational skills, with at least one year of experience in a related field. Proficiency in MS Office programs is essential. Work from home is available occasionally depending on management discretion and circumstances.

Qualifications

• Good knowledge of global and local PV regulations required.
• Minimum of 1 year experience in pharmaceutical or service provider.
• Pharmacovigilance reporting experience with drugs and biologics a plus.
• Proficient with coding dictionaries; case narratives (ARISg/Argus preferred).
• Proficient with MS Word/PowerPoint/Excel; strong communication and organization.

Responsibilities

• Assist with preparation of adverse event reporting plans.
• Maintain listing of administrative changes.
• Process and evaluate adverse event reports per SOP.
• Alert Project Management when activities fall outside the SOW.
• Process and evaluate AE reports according to SOPs; write narratives and assessments.
• Ensure data quality to support regulatory documents and reports.
• Assist in reconciliation of clinical and safety databases.
• Contribute to safety reports, authorities responses, and risk assessments.
• Perform literature reviews to identify relevant safety information.
• Liaise with internal/external vendors; clients, patients, and HCPs.
• Review QC of source documents, coding, data entry, reports.

Skills

Good communication

Interpersonal interaction

Organizational skills

Time-management skills

Education

Registered Nurse, Pharmacist, or related degree

Tools

MS Word

PowerPoint

Excel

MS Excel

PowerPoint

Job description

Mindlance is a national recruiting company that partners with leading employers across the country.

Job Description

Work from Home answer:

There is no routine work from home, but we do allow contractors on an occasional basis at the discretion of the manager and dependent on factors such as work volume and the employee being in good standing. Requests to work from home must be made in advance and may be denied at the discretion of the manager. In instances of inclement weather, we would allow our contractor and permanent employees to work safely at home.

Contract duration: 6 months with option to extend.

• Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required
• Maintain a listing of all administrative changes and updates
• Ensure all processes as described are operational
• Alert Project Management when activities fall outside the SOW
• Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating, and causality and expectedness assessment
• Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to ICARSs, aggregate data, and requested line listings
• Assist in the reconciliation of clinical and safety databases
• Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection, and assessment reports
• Perform literature review to identify case reports and other relevant safety information
• Liaise with both internal and external vendors (clients, patients, and HCPs)
• Review/Quality check (QC) of source documents, coding, data entry, report generation, and distribution
• Monitor compliance metrics and ensure appropriate documentation when deficient
• Assist in evaluation and validation of systems to support safety
• Other duties as assigned by management

Qualifications

• Registered Nurse, Pharmacist, or other degree in a science or health‑related field
• Good knowledge of global and local PV regulations and legislation, both pre‑and post‑marketing required
• Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g., CRO) with case processing responsibilities
• Pharmacovigilance (PV) reporting experience with drugs and biologics; experience with safety surveillance of vaccines and medical devices a plus but not required
• Proficient with case processing including use of coding dictionaries, case narratives preferably within ARISg and/or Argus
• Proficient with computer programs (MS Word, PowerPoint, Excel)
• Good communication, interpersonal interaction, and organizational skills are essential
• Ability to manage multiple client projects simultaneously with good time‑management skills
• Fluent in English; additional language fluency a plus but not required