Sr. Pharmacovigilance Associate / PV Project Manager

Multiple Locations: Durham, NC, USA • Canada • Argentina • Mexico

Notice

This position is no longer open.

Requisition Number: 5732

Position Title: Senior Associate, Pharmacovigilance

External Description:

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

What Pharmacovigilance does at Worldwide

Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team is made up of a dynamic group of individuals with extensive experience within the Drug Safety world. From watching drugs progress from First in Human administration to global regulatory approval, we are able to be a part of the full lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze and submit to Investigators, Ethics Committees/IRBs and Regulatory Agencies furthering clinical drug development!

The Pharmacovigilance group is the perfect place to launch or further your career. Here you can utilize your medical background, delve into and maximize those investigative skills and learn new skills with opportunities in Project Management as a Safety Lead with oversight of small to large complex programs.

Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team is made up of a dynamic group of individuals with extensive experience within the Drug Safety world.

From watching drugs progress from First in Human administration to global regulatory approval, we are able to be a part of the full lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze and submit to Investigators, Ethics Committees/IRBs and Regulatory Agencies furthering clinical drug development!

What the Pharmacovigilance Project Manager does at Worldwide

The Pharmacovigilance Project Manager is responsible for managing key client relationships and overseeing a program of studies for a specific client; they will provide pharmacovigilance leadership, management and expertise to staff working on projects within the program. They focus on providing proactive management across a portfolio of studies to ensure continuity and consistency in communication and case processing.

What the Pharmacovigilance Project Manager does at Worldwide

What you will do

Serve as primary point of contact with client as well as internal team to ensure consistency, compliance and quality across projects; oversee the management, monitoring, adjustment and ongoing revision of safety management plans (updates to plans, review of risks and identification of new mitigation strategies); track and monitor PV status for each project; represent PV at key client meetings; may participate in proposal review and budget process, bid defense meetings, authoring department standard operating procedures; may represent PV at sponsor audits as needed.

Provide periodic management level QC of cases to ensure consistency, quality and compliance in case processing; maintain and QC PV section of TMF; generate and provide status reports including line listings and metrics to monitor compliance, progress and quality
Manage deliverables across the PV team: manage change orders and out of scopes; monitor progress and provide oversight and alignment across PV team for consistency, compliance, quality; responsible for liaising and collaborating with other Worldwide Clinical Trials departments working with the same client.
May serve in a line manager capacity with direct reports depending on business needs; provide direct supervision of assigned staff and projects including ensuring:
All pharmacovigilance activities are performed according to applicable regulations and processes; work is performed according to the budgeted scope of work; work is performed within applicable timelines and according to applicable quality standards; provide guidance and coaching to direct reports; escalate any issues or concerns related to study or staff conduct; organize and provide training sessions; participate in staff recruitment and on-boarding; may serve as back-up to senior PV leadership as needed.
Maintain knowledge and understanding of safety related regulations and guidelines; maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope; participate in department and company-wide initiatives as needed.

What you will bring to the role

Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
Excellent understanding of computer technology, and management of relational database systems, including extraction of data.
Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
Excellent organization skills and ability to handle multiple competing priorities within tight timelines. Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities.
Ability to anticipate needs and follow through on all assigned tasks
Ability to effectively receive and provide constructive feedback without becoming defensive. Ability to work well independently, but also able to seek input effectively from others when appropriate.
Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.

Your experience

Bachelor’s degree in a science-related field, or nursing, or equivalent.
Minimum of 5 years of global pharmacovigilance experience (pre-approval clinical trials) across a variety of phases and therapeutic areas
Demonstrated history of strong leadership skills including a minimum of 2 years in a mentorship capacity.

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

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Employment Type: Regular

Community / Marketing Title: Sr. Pharmacovigilance Associate / PV Project Manager

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Durham, North Carolina US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.