Medical Safety Physician - Palo Alto, CA

Jazz Pharmaceuticals Palo Alto , CA 94306

Posted 4 months ago

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

As a member of the Pharmacovigilance, Quality & Safety department, the Director, Medical Safety Physician will be responsible for medical review of individual case safety reports as well as medical review of aggregate safety data. The Drug Safety Physician may also contribute to safety surveillance activities, safety process and convention development, and attend various safety related meetings.

Essential Functions

  • Performs medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment for a assigned cases.
  • Provides appropriate medical interpretation and consistency to adverse event case assessment.
  • Performs aggregate safety data review on an ad hoc basis in order to support department initiatives in process improvement and regulatory compliance.
  • Provides pharmacovigilance and drug safety support for internal and external customers
  • Maintains knowledge of global regulatory authority regulations (especially FDA and EMEA) and apply appropriately to all activities.
  • Contributes to the training, leadership and continuing education for all departmental staff

Key Responsibilities

  • Performs medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and company causality assessments.
  • Provides appropriate medical interpretation and consistency to adverse event case assessment.
  • Provides medical contribution and performs medical review of aggregate reports
  • Provides medical contribution and performs medical review of responses to regulatory authorities
  • Provides medical input into signal management activities (detection, validation, assessment) for assigned products
  • Performs aggregate safety data review on an ad hoc basis in order to support safety evaluations
  • Provides expert input into function/departmental initiatives as part of process improvements and ensuring regulatory compliance.
  • Participates in due diligence activities as appropriate.
  • Provides pharmacovigilance and drug safety support for internal and external customers
  • Maintains knowledge of international regulatory authority regulations (especially FDA and EU/EEA) and apply appropriately to all activities.
  • Participates in departmental activities to ensure internal audit and regulatory inspection readiness
  • Contributes to the training, leadership and continuing education for all departmental staff

Required Knowledge, Skills, and Abilities

  • At least 8+years of experience post-residency, with at least 2 years of clinical experience and 5 years of experience in pharmacovigilance at a pharmaceutical/biotechnology company.
  • Exposure to working relationship with the FDA and other regulatory authorities is preferred
  • Knowledge and understanding of national and international regulatory guidelines and drug safety practices
  • Strong knowledge of individual adverse event case report processing, triage and medical review
  • Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
  • Experience with safety databases (Argus preferred) and safety coding dictionaries (MedDRA, WHODRUG)
  • Excellent oral and written communication skills
  • Excellent teamwork and interpersonal skills are required

Required/Preferred Education and Licenses

  • M.D. degree required
  • Medical licensure in at least one state preferred
  • Board certification in a specialty appropriate to the products of Jazz Pharmaceuticals preferred

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

medical BACH_19b52f event company case


Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Vans PT Sales Associate (St...

VF Corporation

Posted Today

VIEW JOBS 7/20/2018 12:00:00 AM 2018-10-18T00:00 Job Description Vans: Be a Part of the Original"It was never about waving the brand like a flag, it was always about the people" – Paul Van DorenVans is the original action sports footwear company rooted in authenticity and creativity. Founded in 1966, Vans has thrived on a legacy of impacting our greater community through Vans' four pillars: action sports, music, art and street culture. We are constantly inspired by the expressive creators within our company and community as they bring new and innovative perspectives to help shape and transform the future of our business.At Vans our culture sets us apart and it influences everything we do. Everything we do supports creativity and we are driven by our five values. We are determined. We are connected to our consumers and to each other. We are inclusive. We are expressive and Fun. And most of all, we are a family. Vans is a subsidiary of VF, the world's largest apparel and footwear company comprised of over 30 brands. We are the leading drivers of retail as our global footwear, apparel and accessory brand is available in 170 countries worldwide. As we continue to expand, we take great measures in developing and growing our people. Vans is founded on a culture of learning. We take great pride in our ability to facilitate learning opportunities to our field leaders and store employees through a blend of on-the-job training, workshops and self-paced online learning. Each employee is empowered to take ownership of their development, and encouraged to take advantage of the tools that make the most impact on their personal growth and the growth of the business. By joining the Vans family, you will be immersed into an environment of incredibly supportive and collaborative people. We work very hard across a multitude of large initiatives to bring the Van Doren spirit to life. We live for what we do.Sales Associate: Become the Newest Member of the Vans Family Off the Wall is a state of mind. Thinking differently and creating self-expression. As one of our passionate, fun and dedicated Sales Associates, you will bring Off the Wall to life. You will thrive in an authentic environment where we focus on elevating the customer experience by creating an industry leading atmosphere for our customers. As our Sales Associate, you will maintain the voice of our brand by engaging our customers in genuine conversation and selling our original and innovative product. You are an invaluable part of a team where individuality and authenticity are encouraged. If you have passion for Vans and are looking for a company dedicated to providing development opportunities to grow employees into the future business leader of tomorrow, the Vans family is for you. Vans. The Original since 1966. How You Will Make a Difference: • Sales: Demonstrates a customer centric mindset by modeling selling behaviors with a passion for the brand, customer, and the product. Delivers results in their role that contribute to the store's success. Aware of and accountable to store and individual sales goals.• Brand Experience/Customer Service: Exemplifies an optimistic and energetic presence through team collaboration while building strong relationships with customers to maximize customer loyalty. Provide solutions and inspiration to customers about the brand.• Working with the Team: Works collaboratively with the store team to achieve store objectives and sales results. Maintains a positive attitude and is flexible to the changing needs of the customer and the business. • Store Standards: Ensures product is always available to the customer and represented in a compelling way that is consistent with visual guidelines. Ensures the store is consistently recovered and customer ready every day meeting brand standards on the sales floor and in the back stockroom areas. • Loss Prevention, Safety, and Compliance: Adheres to policies and procedures, standards and practices, and company directives. Protects company assets. Complies with company safety, security, and shrink avoidance policies and programs. Reports any and all concerns to management.• Professional Conduct: Models behavior that respects the background, experience, and cultural differences of others, while upholding the integrity and values of the VF Corporation and Vans. Skills for Success: • Previous retail or service-oriented experience preferred but not required• Ability to work with a team to exceed sales results• Ability to meet business goals by meeting and exceeding sales goals• Regularly interacts with the public in an often crowded and noisy interactive store environment• Engaging verbal and nonverbal communication skills • Ability to work in a fast-paced environment• Able to meet performance expectations • Ability to deliver a high level of customer service in a retail environment • Ability to work a flexible schedule to meet the needs of the business; will require weekends, evenings, and holidays Special Physical and/or Mental Requirements: • Standing required for entire work shift • Bend, lift, open, and move product up to 50 pounds as needed Core Competencies: Customer Focuso Recognizes and respects both types of customers, those that shop in our stores and those that work in our storeso Sets the expectation for 'Brand Right' customer engagement - engaging customers in interactions that convey knowledge and passion for the brand, living and breathing Vans service philosophy, values, and spirito Is knowledgeable about Vans product and shares that knowledge with the customero Actively engages with customers to understand their needs and provide a positive experience going above and beyond to meet the customers' needso Makes the best impression in all situationso Identifies customer service opportunities and is dedicated to exceeding the expectations of all customerso Uses understanding of customer needs to ensure customer satisfaction and to prevent service issues from occurring; promotes customer service as a valueo Assures customer satisfaction and seeks to drive business through selling and customer engagementCommunicationo Communicates in an engaging way with a respectful tone and mannero Possesses a Brand Winning Attitude and approaches each challenge with positivity and communicates in an energetic, friendly, fun, precise, efficient, original, and genuine wayo Listens actively and accurately in a variety of contexts and situationso Listens and asks questions to understand viewpoints of otherso Approachable exhibiting positive communication skills including non-verbal body languageo Communicates issues and concerns in a timely mannero Organizes communication and ensures understandingo Maintains audience's attention and adjusts to audienceo Communicates authentically, with credibility and confidenceo Demonstrates a positive influence on others and is committed to the success of the brandContributing to Team's Successo Actively participates in a positive way with other members of the team to achieve successo Genuinely cares about people and earns the respect and confidence of otherso Listens to and fully involves others in team decisions and actions; values and uses individual differences and talentso Shares important or relevant information with the team being cooperative and constructive when working with a teamo Adheres to the team's expectations and guidelines; fulfills team responsibilities; demonstrates personal commitment to the teamWork Standardso Sets standards for excellence. Is proud of who they are and the company they work foro Demonstrates the traits, inclinations, and outlooks to engage with customers and drive saleso Ensures high quality. Dedicates required time and energy to assignments or tasks to ensure that no aspect of the work is neglected; works to overcome obstacles to completing tasks or assignmentso Has high personal standards and strives to achieve personal best every day o Accepts responsibility for outcomes (positive or negative) of one's work; admits mistakes and refocuses efforts when appropriateo Encourages others to take responsibility: Provides encouragement and support to others in accepting responsibility; does not accept others' denial of responsibility without questioningAdaptabilityo Views challenges as opportunities and is open and receptive to changeo Actively seeks information about new work situations; strives to understand the rationale and implications for changes in work responsibilities or environmento Treats change and new situations as opportunities for learning or growth; identifies the benefits of change; speaks positively about the change to otherso Quickly modifies behavior to deal effectively with changes in the work environment; tries new approaches appropriate for new or changed situations; does not persist with ineffective behaviors. o Exercises flexibility and patience in difficult situations VF Corporation Palo Alto CA

Medical Safety Physician - Palo Alto, CA

Jazz Pharmaceuticals