Job description
Location: Fully Remote (US)
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Contract Length: 12 Months
Pay Rate: $40-50/hr including individual healthcare coverage
3-5 years PSUR (Periodic Safety Update Reports) writing experience required
The Pharmacovigilance and Patient Safety (PPS) organization works collaboratively and strategically with
colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile
of company products to protect patients worldwide.
Within the PPS Organization, The Medical Device Safety team is a highly diverse department that plays a
critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical
oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a
range of product initiatives. As a member of the team, you are at the forefront of working with leaders to
identify critical priorities and drive high-value projects that make an impact on safety of our patients.
Activities performed under this team:
- Assisting with ongoing continuous improvement projects spanning across departmental needs
- Providing support for training and automation efforts
- Identify regional label variances and build tool to capture info for priority products and main
- competitors
- Support medical safety consultation activities in matters related to risk/benefit and proper product
- safety usage as needed.
- Gain understanding of risk management regulations, standards, and guidance for medical devices
- and combination products.
- Participate in root-cause investigations into device failures and human factors-related use errors.
Qualifications
- Bachelor of Science
- PH.d, PharmD, or RN highly preferred
Desired Skills:
- PSUR (Periodic Safety Update Reports) Experience Required
- Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
- Knowledge of Research & Development and an understanding of regulatory guidelines /
- requirements related to R&D Medical Devices/Combination Products (e.g., ICH, GCP, CFR, EU-MDR,
- safety reporting)
- Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, other database
- tools)
- Ability to effectively interact with and influence others without direct reporting relationships
- Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
Core Essential Skills:
- Ability to Meet Challenging Milestones with results orientation - Skilled
- Strategic Decision Making and Negotiation - Skilled
- Facilitating Change and managing conflicts - Skilled
- Ability to Problem Solve Independently & with Others - Highly Skilled
- Business Organization & Industry Awareness - Highly Skilled
- Cross Functional Relationships and communication skills - Highly Skilled
- Execution / Results / Process Improvement - Highly Skilled
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
