Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.
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.
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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.