Pharmacovigilance Project Lead (6 to 12 month home working project)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in the United States, United Kingdom, Australia, and Japan, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

The Pharmacovigilance POD Lead will manage and guide a dedicated Pharmacovigilance (PV) team. This role will collaborate with the Pharmacovigilance Program Manager and may also act as the client contact for case management and reporting functions.

• 6-12 month position

Safety Program Oversight & Project Leadership

• Provide oversight, direction to PV staff working on this dedicated client, including, but not limited to PV Lead, Senior PV Specialists, PV Specialists, PV Coordinators, and Submissions Specialists.
• 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.
• Provide oversight and direction of PV deliverables as a PV subject matter expert, encompassing all activities throughout the duration of a project/program.
• Continually seek out ways to enhance client service experience both internally and externally.
• 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).
• Provide guidance to assigned client on PV industry best practices, regulatory recommendations and operational processes.

Case Management and Submissions Oversight

• Ensure all ICSRs are processed in accordance with client-specific requirements that fall outside of ProPharma Group SOPs and conventions.
• Perform case QC for assigned client(s), as applicable.
• 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.
• Ensure all case processing is compliant with any Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVAs) for assigned client(s).

Quality Assurance Support

• 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).

Pharmacovigilance Case Processing

• Conduct daily case processing of adverse event, product complaint cases
• Case and event assessment
• Identify events and code using MedDRA
• Determine seriousness and expectedness of each event.
• Determine overall case assessment of seriousness and expectedness.
• Perform assessment review, capture causality
• Case follow-up activities
• Identify information to be collected during follow-up
• Conduct follow-up calls and prepare written communications to obtain follow-up information
• MedWatch, CIOMS, E2B Preparation
• Conduct daily review of medical information cases
• Write case narratives and review MedWatch/CIOMS/E2B forms
• Provide signal detection analysis within aggregate reports
• Other duties as assigned.

• 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.
• Flexible leadership style and team building skills.
• Proficient in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), SharePoint (or other management/shared content/workspace) and internet.
• Working knowledge and understanding of the legal and regulatory environment within pharmaceutical industry.
• Excellent internal and external customer service skills.
• Strong verbal, written and interpersonal communication skills with clients and internal staff.
• Excellent attention to detail.
• Excellent organization, prioritization, project management and delegation skills; with strong attention to detail.
• Able to work independently and collaboratively in a multidisciplinary team.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Life Science Degree
• 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
• Required: 2 years employee management experience
• 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: Experience working with safety databases or equivalent

Candidate must be legally eligible to work in the United Kindom.

Please note this is a 6-12 month project position.

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