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Location

Connecticut | United States

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Job description

Position Summary:

Reporting to the Director, Post Market Surveillance, the Medical Affairs Manager is responsible for

providing oversight and day to day management of all activities pertaining to pharmacovigilance

operations for Edgewell over the counter products. The Medical Affairs Manager has expertise in US

as well as global guidelines and regulations and ensures the uniform and timely processing and

reporting of adverse events to global regulatory authorities . The Medical Affairs Manager manages

internal pharmacovigilance activities as well as external service providers and ensures

Pharmacovigilance responsibilities are of high quality and timelines are adhered to.

Responsibilities

• Manage and maintain a highly compliant pharmacovigilance (PV) program for all business units
• Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for adverse event reporting
• Supervise daily workload of Medical Affairs team to ensure compliance with global regulatory reporting timelines and requirements
• Review, assess and report serious adverse events to regulatory agencies, as required
• Manage and oversee service providers to ensure Pharmacovigilance responsibilities and deadlines are being met. 
• Monitor Corrective and Preventive Actions (CAPA’s) relating to non-compliance issues and findings.  Maintain and track all CAPA’s related to adverse events
• Coordinate and oversee workload for external providers to ensure accurate and timely generation of all periodic reports and MedDRA coding.
• Ensure internal processes and procedures are well documented and support regulatory guidelines
• Develop and maintain standard operating procedure (SOPs) and work Instructions (Wis) relating to adverse events
• Conduct standard quality checks of adverse event data to ensure compliance
• Develop and present adverse event training to internal and external partners
• Assist and support internal and external audits and inspections

Qualifications

• Bachelor’s or master’s degree in Healthcare, Science discipline, or related filed required
• A minimum of 6+years of pharmacovigilance experience
• Strong understanding of medical terminology
• Strong interpersonal and problem-solving skills; ability to work in a highly collaborative environment and work effectively with team members and key stakeholders across all business units
• Detail-oriented with strong analytical and strategic thinking skills
• Excellent communication skills, both written and verbal, ability to articulate in a clear and concise manner across various levels of the organization
• Highly organized with strong attention to detail, adaptable and able to succeed in a dynamic fast-paced environment
• Strong project management skills including a demonstrated ability to prioritize and handle several projects simultaneously while meeting tight deadlines
• Self-motivated and goal-oriented; ability to work independently with minimal supervision

Work Environment

• Remote work environment
• Ability to lead engaging meetings virtually for Global audience
• Travel may be required to support business needs.  Approximately 2-3 domestic trips annually.

The salary range for this position is $96,000 - 144,000. Actual base salary offered to a candidate may vary based upon factors including, but not limited to, relevant experience, time in role, base salary of internal peers, prior performance, business sector, and geographic location. In addition to base salary, the competitive compensation package may include, depending on the role, participation in an incentive program linked to performance. 

#LI-LC1

#REMOTE

Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.

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Job tags

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Salary