Location: Fort Lee, NJ, Cambridge, MA, Emeryville, CA or San Mateo, CA
Department: Pharmacovigilance and Drug Safety
Reports To: Senior Director, Safety Science
PharmD, RN or PhD in a biological science
MD desirable but not required
Hours: 40 hours/week
Over-time may be required on occasion
The person in this position collects analyzes safety data to allow medical interpretation and action concerning potential and actual safety signals. If a safety signal is identified the person helps create and monitor risk mitigation activities associated with the safety signal.
Essential Functions of the job:
- Working with Safety Operations prepare and provide an assessment of aggregate reports required for routine signal detection activities
- Working with Safety Operations ensure that safety data required for ad hoc regulatory queries complies with the request
- Working with Safety Operations ensure that outputs of safety data from both safety and clinical trial databases meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities and work with the Safety Science Medical Directors in creating the required documents
- Work with Safety Science Medical Directors in the creation and review of safety input for IB and informed consents and the answering of ad hoc safety queries from ethics committees
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills : Working knowledge of Microsoft Office and ARGUS. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.
Other Qualifications : 5-8 years in pharmacovigilance in an analytical role
Travel: Less than 10%