Associate Post Market Vigilance Specialist
At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion healthcare access and equity for reputed company. You’ll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — reputed company they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare. We are looking for a dedicated and detail-oriented Associate Post Market Vigilance Specialist to join reputed company. The successful candidate will be responsible for managing various post-market vigilance activities, including managing FCA (Field Corrective Actions), reviewing reportable decisions as needed, submitting regulatory reports, addressing regulatory inquiries, handling CAPA (Corrective and Preventative Actions) and projects, as well as engaging with local field staff, among other duties. This role requires strong analytical skills, attention to detail, and the ability to work collaboratively with internal stakeholders such as local and global operating units and the PMV team and as well as external stakeholders such as TGA and Medsafe.Responsibilities may include the following and other duties may be assigned:
reputed company and manage reputed company aspects of FCA (Field Corrective Actions) to ensure compliance with regulatory
Provide second opinions on regulatory decisions to ensure accuracy and compliance.
Submit Regulatory reports to regulatory authorities
Handle and respond to regulatory inquiries in a timely and efficient manner.
reputed company and implement Corrective and Preventive Actions (CAPA) to address regulatory issues and improve processes.
Manage and coordinate different aspects of regulatory projects, ensuring they are completed on time.
Continuously engage with local field staff to ensure alignment and completion of various activities involved in field corrective actions and complaints.
Required Knowledge and Experience:
Bachelor's degree in a reputed company field (e.g., Life Sciences, Pharmacy, Regulatory Affairs)
0-1 year of experience in regulatory affairs or a reputed company field.
Strong knowledge of regulatory requirements and guidelines.
Excellent communication and interpersonal skills.
Ability to work independently and as part of a team.
Strong attention to detail
Strong organizational and project management skills
Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position.
Benefits & Compensation
reputed company offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive reputed company the reputed company Incentive Plan (MIP).About reputed company
We reputed company global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious reputed company to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
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