Senior Medical Safety Specialist

Job#: 1372273

Job Description:

Apex Systems is looking for Senior Medical Safety Specialists in the Minnetonka, MN and Marlborough, MA areas!

**For immediate consideration please send an updated copy of your resume to Megan at [email protected] with "Senior Medical Safety Specialists" in the subject line**

Title: Senior Medical Safety Specialist

Hours: 6AM - 2:30PM

Duration: Starting at 12 months

Location: Minnetonka, MN or Marlborough, MA but well qualified candidates may be considered for remote position

Summary:

• This role manages surveillance processes across a wide range of business unit products and disease states related to Urology and Pelvic Health.
• The Senior Medical Safety Specialist collaborates with cross-functional team members to provide medical input and oversight throughout the product lifecycle as an advocate for patient safety.
• Completes accurate, timely, and consistent medical assessments of adverse events and potential adverse events.
• The role performs work under limited supervision of the Medical Director or with consultation from Medical Safety peers and Safety Trial Managers.
• Major interfaces include Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center, and functional management.

Responsibilities:

• Applies knowledge and experience of clinical medicine to a wide range of medical devices in one or more therapeutic areas including but not limited to Womens Health (gynecological surgery, pelvic organ prolapses, urinary incontinence), Mens Health (erectile restoration, urinary incontinence), Prostate Health (benign prostatic hypertrophy), and Stone (urinary tract stones).
• Performs medical reviews and assessments of adverse events from multiple sources which include clinical trials, complaints, Medical Device Reports; identifies safety issues; and potential safety signals.
• Performs pre-scheduled and ad hoc analyses of data from multiple sources and presents data by communicating accurate, succinct summaries at team and cross-functional meetings.
• Represents Medical Safety at multi-functional team safety trend meetings.
• Works closely with Medical Director to produce clear and concise communications of complex data.
• Effectively escalates potential patient safety issues for decision-making and/or potential action by senior leadership.
• Provides medical safety support to maintain risk documentation for existing products and helps develop risk documents for new products in development.
• Applies medical device regulations and standards appropriately (globally).
• Supports team in internal and external audits.

Qualifications:

• Bachelor's level degree or equivalent in healthcare/life science related field
• 5 + years of direct patient care experience or experience in healthcare setting required. (Examples of health-related field professionals include but are not limited to registered nurse, physicians assistant, and nurse practitioners.)
• Excellent oral, written and computer skills required
• Familiarity with or experience in urology disease states (Preferred)
• Post Market Surveillance experience (Preferred)
• Ability to manage complex projects (Preferred)

**For immediate consideration please send an updated copy of your resume to Megan at [email protected] with "Senior Medical Safety Specialists" in the subject line**

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.