Penfield Search Partners
Contact: Allie Spink – aspink@penfieldsearch.com
Job Description: Reporting to the Pharmacovigilance Scientist Lead, the Pharmacovigilance Scientist will support PV Scientist Team in the overall safety management of assigned clinical trials, from planning to close out, ensuring compliance with regulatory reporting timelines and data exchange governed by partner Pharmacovigilance Agreements
- Assist Pharmacovigilance Scientist Leads with the review of ICSRs, AESIs, and Pregnancies
- In collaboration with the Pharmacovigilance Scientist Lead, review study plans and documents
- Retrieve safety data and support the preparation of safety materials for monthly Safety Review meetings
- Manage Safety Regulatory Report timelines, ensuring planning meetings, data requests and adherence to timelines for compliant regulatory and partner submissions
- Liaise with vendor writing team and internal stakeholders for aggregate report contributions, ensuring timely response
- Contribute to review of eTMF management including maintenance and oversight
- Manage SRC, ESC, and Joint Safety Committee Meetings – Assisting with material preparation, scheduling, documentation, and archiving
- Liaise with CROs to support safety management between PV FSP and Clinical CRO
Qualifications:
- 5+ years’ experience at biotechnology or pharmaceutical company or CRO supporting clinical trials
- Minimum B.A./B.S. degree in science/healthcare field preferred
- Basic knowledge of drug development and FDA GCP and ICH regulatory guidelines
- Excellent oral and written communication, with particular attention to detail
- Excellent organizational and problem-solving skills
- Ability to multitask, switching to higher priority responsibilities with workload
- Advanced-level proficiency with MS Word, Excel, PowerPoint, Smartsheet and Adobe Acrobat
- Familiarity with MS Project, SharePoint, and MS Teams
- Demonstrated passion for the company’s values with a commitment to deliver results against our mission
- Local Travel ~10%