Medical Safety Physician
We are currently searching for a skilled professional to join a well-known client’s team as a Medical Safety Physician, in Princeton, New Jersey. The Medical Safety Physician supports safety teams in all aspects of pharmacovigilance and risk management activities for assigned products both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company Core Safety Information, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities, and reports risk management plan (RMPs/REMS) and individual case safety reports. He/she will work in cross-functional teams with counterparts in regulatory, clinical development, pre-clinical, manufacturing/quality, global pharmacovigilance and other functional areas to identify, evaluate and communicate safety issues relevant to his/her assigned products. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Analysis of comprehensive product information, synthesis, risk-benefit assessment and reporting
- Proactive Monitoring of product safety profile from FIH throughout lifecycle
- Primary ownership and accountability for product signaling review, analysis, delivery and approval
- Timely action and communication of finding safety governance forums
- Leadership and ownership of internal safety governance bodies (SMT, JSMT)
- Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
- Contribution and review of safety documents from individual patient data to submission-level safety documents
- Partnership with GCD Project Leaders on Program Development from Phase I to LCM regarding safety and risk-benefit topics and decisions
- Contribute to label development, scientific regulatory responses. Review and Approve Coding
- Active, Regular Utilization of Data Review, Reporting and Visualization Tools & Systems
- Provide medical and PV oversight and key input to protocols, investigator brochures, safety summaries, clinical study reports, regulatory reports (periodic, ad hoc), labeling changes
- Train drug safety associates and contribute to mentoring and on-boarding of new colleagues
- Serve as the subject matter expert from a safety perspective
- Work extensively with colleagues from across the globe
- Participate in department decision making and strategy
- Ensure all activities are of the highest safety and ethical standards
- Travel (approximately 10-25%)
- Requires a strong medical background evidenced by clinical training
- Solid knowledge of FDA and global PV regulations
- Knowledge of clinical trials, good clinical practices, and ICH guidelines
- Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical industry
- Experience with both development and product launch/post marketed products preferred
- Ability to act as in-house authority/leader in Safety and Pharmacovigilance; and be fully accountable for Safety of assigned products
- Experience interacting with global regulatory authorities
- Oncology or Neurology experience a plus
- Experience in working in a global setting
- Experience with industry software and databases
- Sound computer skills and be well versed in the use of Microsoft Office
- Excellent verbal and written communication skills
- Good presentation skills
- Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks
- Strong leadership skills
- Ability to adapt to a dynamic work environment
- MD degree with US medical license (preferred)
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.