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An established industry player in the pharmaceutical sector is seeking a dedicated professional to oversee Safety Operations in Oncology. This role offers the chance to engage in meaningful work that enhances patient safety and contributes to drug development. With a flexible remote work option, you will collaborate with cross-functional teams to influence drug safety strategies while ensuring compliance with global regulatory requirements. This position is ideal for someone with a strong background in pharmacovigilance and a passion for innovative medicines that address serious health issues.
Employer Industry: Pharmaceutical Industry
Why consider this job opportunity:
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees
- Opportunity to participate in short-term and long-term incentive programs
- Role offers flexibility for remote work within the U.S.
- Engage in impactful work that contributes to patient safety and drug development
- Collaborate with cross-functional teams to influence drug safety strategies
- Chance to work with innovative medicines that address serious health issues
What to Expect (Job Responsibilities):
- Oversee the accuracy, completeness, and timeliness of Safety Operations scientific activities and deliverables for Oncology
- Serve as the point of contact for Product Safety Teams regarding Adverse Event data for global regulatory responses
- Collaborate with Data Management to extract necessary data and reports
- Lead cross-functional collaborations with stakeholders to establish harmonized ICSR processes
- Participate in audits and inspections, preparing relevant materials related to Adverse Event data
What is Required (Qualifications):
- Bachelor’s degree with a related health sciences background; licensed healthcare professional (RN, BSN, BS, BS Pharm, PharmD)
- Minimum of 5 years’ experience in the healthcare industry with a strong understanding of drug development
- At least 3 years of pharmacovigilance experience required
- Strong understanding of current global regulatory requirements impacting pharmacovigilance
- High emotional intelligence and strong relationship management and communication skills
How to Stand Out (Preferred Qualifications):
- 2 years of previous experience as a Product Manager or equivalent preferred
- Demonstrated ability to collaborate and influence cross-functionally and globally
- Experience in cross-functional initiatives related to drug safety
- Strong leadership presence and communication skills
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