Signal Detection Team Lead (Home Working) Project Position

Signal Detection Team Lead (Home Working) Project Position

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Job Description

The Pharmacovigilance Team 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 signal detection functions.

• 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.

• Participate in Signal detection activities.
• Ensure signal detection is conduct in accordance with regulatory requirements.
• Support the aggregate report/signal detection team with gathering appropriate data for signal detection.
• Manage outcomes from signal detection activity.

• 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).
• Other duties as assigned.

Qualifications

• 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: 7+ years of experience in pharmacovigilance
• Required: 4+ years of experience in signal detection for pharmacovigilance.
• Required: 2 years employee management experience
• Preferred: Experience working with large data sets.
• 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

Additional Information

Candidate must be legally eligible to work in the United States or United Kingdom.

Please note this is a fixed-term position lasting through June 30th, 2022.

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