
Supervisor, Medical Events Group
- Alameda, CA
- $98,000-196,000 per year
- Permanent
- Full-time
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
- Responsible for supervising personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.
- Responsible for ensuring Vigilance Reports are completed and submitted in a timely matter in accordance to applicable procedures by the Medical Events Group staff.
- Responsible for working with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.
- Responsible for providing subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.
- Responsible for monitoring people and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.
- Responsible for identifying any trends that are found during the medical event process and alerting management in a timely manner.
- Performs verification of vigilance reports, as well as verification of data compiled for metrics, risk evaluations, CAPAs and various other MEG related activities.
- Assists the Medical Events Group Associate Director in performance evaluations and administrative duties.
- Bachelors Degree in Science, Medical (Physician, Nursing, Pharmacy) or equivalent in a technical discipline.
- Minimum 3 years of overall experience working in a quality related role, or equivalent time in clinical laboratory, medical, or nursing experience.
- Demonstrates initiative, problem-solving, and critical-thinking skills. Strong written and verbal communication skills.
- Knowledge of FDA/International guidelines for drug/device safety reporting requirements.