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Snr. PV Scientist
Job Summary
Beacon Hill Pharma is currently hiring a Snr. PV Scientist for a direct opportunity in the Raritan, NJ area.
The PV Scientist will support the management team within Safety, with safety deliverables to include aggregate reports, and also serve as point person for specific assigned reports. The therapeutic area will within Oncology and crossover to CV/Metabolism. The PV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues including oversight of aggregate reporting for assigned product.
Roles and Responsibilities
- Overseeing aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
- Safety surveillance activities for assigned products
- Review study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information
- Signal detection, evaluation, and management
- Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Provide safety contents for risk management plans
- Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.
Basic Qualifications:
- Education: RN, PharmD
- Minimum of 6 years pharmacovigilance experience, including experience in aggregate safety reports and safety signal management
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
Beacon Hill. Employing the Future™
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