Pharmacovigilance Scientist

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Job description

**Kelly is actively recruiting for a Direct Hire - Pharmacovigilance Scientist in Manhattan, NY.**

Reporting to the Chief Medical Officer & Acting Head of Pharmacovigilance, the Pharmacovigilance Scientist at Client will manage all activities related to the performance of drug safety at Client. The ultimate objective is to ensure patients, their caregivers, investigators, site staff and the clinical development team have the most up-to-date insights and information about the safety of Client's products and the course of action to take should concerns about patient safety arise in clinical trials.

The Pharmacovigilance Scientist will be responsible to ensure:

• the central coordination and up-to-date oversight into all activities required to ensure the safety of patients that participate in Client clinical trials and are exposed to Client's products.

• the timely delivery of all required drug safety content and documents required by competent authorities from Client in applicable constituencies worldwide.

• the most recent and up-to-date drug safety standards, techniques, and regulations are implemented throughout the portfolio of Client's PV activities.

• procedures are in place and ready for execution should concerns about patient safety arise

• drug safety is pro-actively integrated into drug development activities

**Responsibilities**

The Pharmacovigilance Scientist will have responsibilities which include, but are not limited to, the following:

• Design and perform analyses of safety information for signal detection

• Manage interface with drug safety meetings (PV team, DSMB/DMC and SAC meetings)

• Maintain a program plan of all activities and deliverables related to drug safety

• Maintain a central repository for all matters related to drug safety

• Manage the external PV services provider and account for the timely execution of contracted activities

• Set up procedural standards for the conduct of PV activities across Client

• Ensure any PV Agreements/Safety Data Exchange Agreements with business partners comply with PV standards and are implemented and followed

• Monitor compliance with regulatory and company standards for safety data management

• Conduct root cause analysis of procedural deviations and implement CAPAs as required

• Maintain records of PV activities at the disposal of regulatory auditors

• Support internal PV audits and regulatory inspections

• Author, co-ordinate and review PV-related documents including periodic reports (e.g. DSURs), SMPs, SAE reconciliation plans, RMPs, RSIs

• Educate the organization on critical developments and regulatory guidance related to drug safety (FDA, EMA, MHRA, PMDA and others, where necessary)

• Represent drug safety in product team meetings and all activities where drug safety is critical to the success of the company and its products

• Actively pursue continuous improvement of the PV system, maintain up-to-date knowledge of international PV requirements, and complete assigned training on time

**Qualifications & Experience**

• Graduate-level degree in life sciences

• Minimum of 5 years of relevant experience in pharmacovigilance, drug safety, regulatory affairs or clinical trials

• Demonstrated experience in key activities and responsibilities for the role

• Strong analytical skills

• Attention to detail

• Excellent written and verbal communication

**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**

**_\#TJP2021_SPEC_**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()

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