- Doctoral Degree
- Bachelor's Degree
- Master's Degree
- Communication Skills
- Project Leadership
- Relocation Assistance
- Work From Home
Job Locations (All) | US-Remote | US-VA-Charlottesville | Canada-BC-Victoria | US-IL-Deerfield | US-PA-Blue Bell
Posted Date 1 month ago(1/15/2020 9:45 AM)
This position is office-based 3 days a week and work from home 2 in any of the following PRA locations with relocation assistance provided for the right candidate: Blue Bell, PA; Charlottesville, VA, Boston, MA; Deerfield, IL or Victoria, Canada.
This position can also be remote-based in the continental United States with 50% travel.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are an experienced drug safety leader who has led services such as providing aggregate safety reports, benefit-risk assessments, epidemiology reports, safety/risk management aspects of observational studies, signal detection and investigations, design and analysis of safety studies, Risk Management Plans (RMPs) and risk minimization activities applicable to drugs, biologics and devices throughout the life-cycle of a product.
What will you be doing?
Provides technical oversight to project teams and contributes to project deliverables in the areas of cumulative safety reports, benefit-risk assessments, epidemiology, signal detection and investigations, design and analysis of safety studies, risk management plans and risk minimization activities, pharmacovigilance audits and inspection preparation including generation of a project plan in close cooperation with project team.
Supports the implementation of processes, systems and tools to improve efficiencies in company services.
Participates in developing new and existing business by attending sales presentations.
Ensures that project staff fulfills their responsibilities in accordance with company policies, procedures, and SOPs.
Creates an environment that encourages learning, self-improvement, and career development for staff.
Maintains familiarity with current industry practices and regulatory requirements that affect benefit/risk evaluations, NDAs/BLAs/MAAs, and changes to labeling and marketing authorization.
What's in it for you?
This team is the kindest and most brilliant in the industry. You will work with folks who are passionate about what they do. Leadership and who you report into is important. With this position, it doesn't get any better.
Interested in a kind manager with super experience in the role to invest in you and grow you? Apply now to learn more because this might be your role.
What do you need to have?
Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required
Substantial experience in the pharmaceutical industry with at least 5 years of experience in a leadership position.
Profound knowledge of regulatory requirements for human drugs, biologics, and/or devices.
Proven history of successful interaction with internal and external customers.
Effective written and oral communication and presentation skills.
Reads, writes, and speaks English; fluent in host country language required.
Substantial experience in project leadership and management of technical staff.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences.
Postgraduate degree in epidemiology, statistics or public health or equivalent degree preferred.
Experience in interactions with regulatory authorities, IRBs/Ethics Committees, and medical community.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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