Pharmacovigilance Project Specialist

Premier Research; United States; Remote; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

Premier Research is seeking a Pharmacovigilance Project Specialist to join our PV and Records Management team in the United States. You will coordinate cross-functional study teams to ensure PV project delivery and regulatory compliance.

The role requires a Life Sciences degree, 1 year of relevant experience, knowledge of ICH/GCP and FDA/EU regulations, and strong MS Office skills. Fluent English is essential, and you will support audits and TMF activities as needed.

Qualifikationen

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred.
• Experience with Pharmacovigilance preferred
• Basic knowledge of ICH/GCP regulations
• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Basic knowledge of project management terminology and guidelines
• Strong computer skills in MS office suite required
• Fluent in English

Aufgaben

• Partners with Drug/Device Safety Officers (DSOs), Safety Project Managers (SPM), or more senior-level management to ensure overall PV project delivery through coordination and oversight of the cross-functional study team (including Project Management, Regulatory, Clinical Operations, Biometrics, Vendors, and Medical Affairs).
• Ensure compliance and adherence to standard operating procedures (SOPs) and ICH/GCP best practices in all responsibilities assigned.
• Partners with the DSOs, SPMs, and functional leads (where appropriate) to support team communications and documentation internally and externally by maintaining internal and external project team contact lists and ensures effective communication during internal and external team meetings by developing agendas, capturing minutes, and managing the action/decision log.
• Partners with the Safety Project Managers (SPM) or more senior-level management in developing, maintaining, and updating financial tools to track project budgets which helps to identify and track out of scope services.
• Generates routine SAE, SUSAR, and AESI report listings for dissemination to Sponsors or internal team members (i.e., for SAE reconciliation or monthly sponsor communications).
• Supports the SPM or more senior-level management with the collation of key performance indicators and/or Governance slide deck development.
• Ensure assigned projects are audit ready, i.e., project tasks are completed in accordance with Safety Management Plans, project plans, and SOPs.
• Manage TMF document collation and applicable indexing for assigned studies or as needed
• Creates and maintains the required project SOP indices, study team lists, e-mail distribution lists, etc., as applicable.
• Supports the SPM or more senior-level management with kick off meeting slide deck development.
• Creates and maintains the required project training matrices ensuring completion and proper documentation of study specific training requirements as directed by the SPM or more senior-level management.
• Supports preparation for audits and inspections by sponsors or regulatory agencies.

Kenntnisse

Fluent English

MS Office proficiency

ICH/GCP knowledge

FDA/EU regulatory familiarity

Ausbildung

Bachelors in Life Sciences/Pharmacy/Healthcare

Tools

MS Office

Jobbeschreibung

Premier Research is looking for a Pharmacovigilance Project Specialist to join our Pharmacovigilance and Records Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you’ll be doing:

• Partners with Drug/Device Safety Officers (DSOs), Safety Project Managers (SPM), or more senior-level management to ensure overall PV project delivery through coordination and oversight of the cross-functional study team (including Project Management, Regulatory, Clinical Operations, Biometrics, Vendors, and Medical Affairs).

• Ensure compliance and adherence to standard operating procedures (SOPs) and ICH/GCP best practices in all responsibilities assigned.

• Partners with the DSOs, SPMs, and functional leads (where appropriate) to support team communications and documentation internally and externally by maintaining internal and external project team contact lists and ensures effective communication during internal and external team meetings by developing agendas, capturing minutes, and managing the action/decision log.

• Partners with the Safety Project Managers (SPM) or more senior-level management in developing, maintaining, and updating financial tools to track project budgets which helps to identify and track out of scope services.

• Generates routine serious adverse event (SAE), Serious and Unexpected Suspected Adverse Reaction (SUSAR), and adverse events of special interest (AESI) report listings for dissemination to Sponsors or internal team members (i.e., for SAE reconciliation or monthly sponsor communications).

• Supports the SPM or more senior-level management with the collation of key performance indicators and/or Governance slide deck development.

• Ensure assigned projects are audit ready, i.e., project tasks are completed in accordance with Safety Management Plans, project plans, and SOPs.

• Manage Trial Master File (TMF) document collation and applicable indexing for assigned studies or as needed

• Creates and maintains the required project SOP indices, study team lists, e-mail distribution lists, etc., as applicable.

• Supports the SPM or more senior-level management with kick off meeting slide deck development.

• Creates and maintains the required project training matrices ensuring completion and proper documentation of study specific training requirements as directed by the SPM or more senior-level management.

• Supports preparation for audits and inspections by sponsors or regulatory agencies.

What we are Looking for:

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred

• Experience with Pharmacovigilance preferred

• Basic knowledge of ICH/GCP regulations

• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures

• Basic knowledge of project management terminology and guidelines

• Strong computer skills in MS office suite required

• Fluent in English