Manager, Safety & Pharmacovigilance

The Manager of Safety & Pharmacovigilance will be responsible for overseeing all safety and pharmacovigilance activities. This role involves developing and implementing safety strategies, ensuring compliance with global regulatory requirements, and providing expert guidance to clients and internal teams. 

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Leadership and Management:

• Provide direction and leadership for the Safety & Pharmacovigilance department.
• Manage and mentor a team of safety professionals, fostering a collaborative and high-performance work environment.
• Develop and implement departmental goals, policies, and procedures.

Regulatory Compliance:

• Ensure all pharmacovigilance activities comply with global regulatory requirements (FDA, EMA, ICH, etc.).
• Oversee the preparation and submission of safety reports, including DSURs, PSURs, and RMPs.
• Monitor and interpret changes in global pharmacovigilance regulations and guidelines.

Safety Surveillance and Risk Management:

• Lead the development and execution of risk management plans and safety surveillance strategies.
• Oversee the collection, assessment, and reporting of adverse event data.
• Ensure timely and accurate signal detection, evaluation, and management.

Client Interaction and Support:

• Serve as the primary point of contact for clients regarding safety and pharmacovigilance matters.
• Provide expert advice and guidance to clients on safety-related issues and regulatory requirements.
• Develop and maintain strong relationships with clients, ensuring high levels of satisfaction and trust.

Cross-Functional Collaboration:

• Collaborate with clinical operations, regulatory affairs, quality assurance, and other departments to ensure integrated and compliant safety processes.
• Participate in project teams and contribute to the planning and execution of clinical trials from a safety perspective.

Training and Development:

• Develop and deliver training programs on safety and pharmacovigilance processes and regulations.
• Stay current with industry best practices and emerging trends in pharmacovigilance.

• Advanced degree in life sciences, pharmacy, medicine, or a related field (MD, PharmD, PhD preferred)
• Minimum of 8-10 years of experience in safety and pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry
• Proven experience in a leadership role with a track record of managing and developing high-performing teams
• Comprehensive knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.)
• Strong analytical skills and experience with safety data analysis and signal detection
• Excellent communication and interpersonal skills, with the ability to interact effectively with clients and cross-functional teams
• Proficiency in safety databases and pharmacovigilance software systems
• Able to meet NSF/Amarex's hybrid requirements (Germantown office 3 days/week)

Preferred Qualifications:

• Experience in a CRO environment
• Regulatory Affairs Certification (RAC) or equivalent
• Knowledge of therapeutic areas commonly supported by the organization

Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF Employee by a third-party agency without a valid written & signed search agreement, will become sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.

With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification and advisory services and develop the very standards that drive the food, water and life sciences industries worlwide. We empower our clients to navigate shifting regulations to improve consumer health, safety and quality of life.
One of our core values is We Are One NSF. This means that while we’re one team, we embrace the cultural, ethnic, language and demographic diversity that reflects the societies in which we live and work.
Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org.
NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other thi