Department: Pharmacovigilance and Drug Safety
Reports To: TBD
MD degree with subspecialty training preferred
Person in this position provides the medical input needed to interpret safety data derived from any source including clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports in order to identify and evaluate potential safety signals and develop appropriate risk mitigation strategies when a safety signal is confirmed.
Essential Functions of the job:
- Serves as safety expert for all assigned company products either marketed or in development and keeps abreast of the safety profile of all other products in the same class as company products
- Perform regular literature review for all assigned company compounds and other products in the same class for identification of potential safety signals
- Provides oversight of vendor activities related to safety adverse event medical review
- Review adverse event reports from clinical trials on a regular basis as part of the safety signal detection process
- Prepare or oversee safety signal detection and assessment reports
- Provide medical input and review reference safety information in Investigator Brochures
- Responsible for creation and review of the safety information content of the patient informed consent
- Provides the medical input and review needed for the creation of DSUR and other aggregate reports needed to support compounds in clinical development
- Prepares the medical assessment sections of PBRER and other aggregate reports needed to support marketed company products
- Reviews SMP of products in clinical development to ensure that needed safety information is being collected and processed
- Helps prepare and review answers to safety queries from regulatory authorities and IRBs
- Helps prepare and review any aggregate safety analysis in regulatory submissions
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, Familiarity with ARGUS and with data mining techniques
Other Qualifications: 5-10 years’ experience in Pharmacovigilance as a safety physician. Oncology experience preferred.
Travel: Less than 10%