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An established industry player in the pharmaceutical sector is seeking a dedicated professional to oversee safety operations for oncology products. This role offers an exciting opportunity to work on impactful projects related to patient safety and drug development in a collaborative environment. With a strong emphasis on professional growth, you will lead cross-functional teams and ensure compliance with regulatory requirements. The position also provides flexibility for remote work within the U.S., making it a perfect fit for those looking to balance their career with personal commitments. Join a team that values innovation and excellence in healthcare!
Employer Industry: Pharmaceutical Industry
Why consider this job opportunity:
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Opportunity to participate in short-term and long-term incentive programs
- Potential for remote work flexibility within the U.S.
- Chance to work on impactful projects in patient safety and drug development
- Collaborative work environment with cross-functional teams
- Strong emphasis on professional growth and leadership development
What to Expect (Job Responsibilities):
- Oversee the accuracy and timeliness of Safety Operations scientific activities for Oncology products
- Act as point of contact for Product Safety Teams and regulatory responses related to Adverse Event data
- Collaborate with Data Management to extract necessary data and support communication materials
- Lead cross-functional collaboration to establish and maintain harmonized processes for product safety
- Participate in audits and inspections, preparing materials related to Adverse Event data
What is Required (Qualifications):
- Bachelor’s degree in a related health sciences field; licensed healthcare professional (RN, BSN, BS Pharm, PharmD, or advanced degree preferred)
- Minimum of 5 years’ experience in the healthcare industry with strong understanding of drug development
- At least 3 years of pharmacovigilance experience required
- Proficient in case processing processes and current global regulatory requirements impacting pharmacovigilance
- Strong relationship management and communication skills with high emotional intelligence
How to Stand Out (Preferred Qualifications):
- 2 years of experience as a Product Manager or equivalent
- Demonstrated ability to collaborate and influence cross-functionally and globally
- Experience with cross-functional initiatives in a healthcare setting
- Strong leadership presence and influencing skills
- Proficiency in regulations related to drug safety
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