Pharmacovigilance Project Lead (REF7262Y)

Job Description

The Pharmacovigilance Project Lead is responsible for directional leadership of Pharmacovigilance (PV) clients that are contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings. The PV Project Lead acts with limited oversight and ability to research, implement and manage PV services as contracted or requested; is responsible for maintaining a working knowledge of US, Canadian and European PV requirements for investigational and marketed products; and ensures compliance with all applicable regulations and internal SOPs.

Essential Functions Include:

• Provide oversight and direction of PV deliverables as a PV subject matter expert, encompassing all activities throughout the duration of a project/program. Continually seeks out ways to enhance client service experience both internally and externally.
• Prepare and present overall PV strategy and status at client meetings; communicate outcomes to PV management as appropriate.
• Oversee the development of detailed project/program specific Safety Management Plans, Working Practices, Work Instructions and other documents as applicable (e.g. Safety Data Exchange or PV Agreements). Serves as the primary reviewer/approver.
• Provide guidance to assigned clients on PV industry best practices, regulatory recommendations and operational processes.
• Work with PV management to verify adequate project/program resourcing, including annual leave and public holiday coverage.
• Develop and manage integrated PV project/program delivery timelines and risk assessments to report weekly progress.
• Train and mentor PV project team members on project/program specific tasks (i.e. case assessment and processing) and provide a working knowledge of the project/program assigned.
• Manage vendor(s) for outsourced services for assigned projects.
• Work in conjunction with Client Account Manager to verify all work performed is within scope of the contract and budget, and guide development of Change Orders to ensure project profitability.
• Perform other work-related duties as assigned.

• Ensure all ICSRs are processed in accordance with client-specific requirements that fall outside of ProPharma Group SOPs and conventions.
• Perform medical review and/or case QC for assigned client(s).
• Liaison with safety review team to ensure data capture is sufficient for trending and aggregate analysis purposes.
• Develop client-specific data entry conventions as required and ensure staff training/compliance.
• Serve as a resource for Case Processing team for complex cases and escalated inquiries.
• Respond to inquiries from regulatory authorities regarding case information.
• Ensure all case processing is compliant with any Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVAs) for assigned client(s).
• Certify all applicable cross-reporting to regulatory/heath authorities, ethics committees, and investigative sites is handled in a compliant and consistent manner; troubleshoot any process gaps to create robust client-specific cross-reporting systems.

• Serve as primary subject matter expert during audits for assigned client(s) and assumes ownership of response to any client-specific audit findings.
• File any deviations within the eQMS and follow CAPA processes to develop and implement corrective and preventative actions in collaboration with QA.
• Comply with all controlled document requirements and regulatory requirements to ensure quality deliverables.
• Perform monitoring of project/program-specific key performance indicators (KPIs).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements (clinical studies/programs only) or the Pharmacovigilance System Master File (PSMF) for post-marketing programs.
• Collaborate with QPPV and/or LPPV as necessary.

Qualifications

Qualified candidates must have:

• RN, RPh, PharmD or equivalent
• Current healthcare license for degree or equivalent from state or country
• Required: 5 years of experience in pharmaceutical or medical device industry, or equivalent
• Required: 2 years of experience in clinical trials, drug safety or medical/regulatory affairs
• Preferred: Experience working with safety databases or equivalent
• Preferred: Experience analyzing medical/scientific data and writing regulatory reports or equivalent
• Preferred: Proficient understanding of the clinical trial process across Phases I-IV and/or post-marketing safety requirements, ICH GCP and regulations related to Safety and Pharmacovigilance.
• Preferred: Solid understanding of clinical protocols and associated study specifications as pertaining to safety assessment.
• Preferred: Project management experience in a multi-faceted environment.
• Maintain understanding of and ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Proficient in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), SharePoint (or other management/shared content/workspace) and internet.
• Excellent internal and external customer service skills.
• Strong verbal, written and interpersonal communication skills.
• Strong organization and prioritization skills with attention to detail.
• Strong problem-solving skills across a broad range of complexities.
• Able to make clinical decisions and formulate appropriate queries based on sound medical knowledge.
• Able to work independently and collaboratively in a multidisciplinary team.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Minimal travel may be required (up to 10%).

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.