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Associate Director/ Director, Safety Science

San Francisco

JOB SPECIFICATION

ROLE AND RESPONSIBILITIES

  • 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

QUALIFICATIONS

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%

ADDITIONAL NOTES

1057

  • "BioSearch has the experience, network, and know how to identify, recruit and secure top industry talent. I have seen the quality of individuals brought through them into organizations and, as well, have had the privilege of their representation as a candidate. They are consistently of the highest integrity; are tremendous communicators; and seek to optimize process, match and retention to the benefit of all. I give them my highest and unreserved recommendation." -  Todd Yancey, MD - Senior Vice President, Clinical Development – Immuno-Oncology, BeiGene

  • "Working with the BioSearch team has enabled us to build a strong, cohesive group at Gritstone Oncology. They understand who we are, and how we work, and tailor the candidate selection accordingly. Searches are consequently efficient and effective."

    - Andrew Allen, MD, PhD - President and CMO, Gritstone Oncology

  • "When BioSearch says that they have a great candidate for us to consider, I can absolutely count on that to be the case. Our mutual respect for each other has meant that their candidates already arrive for their interview with a positive impression of Sierra as a preferred place to work."

    - Barbara Klencke, MD - Chief Development Officer, Sierra Oncology

  • "When it comes to recruiting companies, I give my highest recommendations to BioSearch. I have worked with them for many years as a client. They consistantly provided high quality candidates for our open positions, greatly reducing our recruiting and hiring timelines. I recently entrusted them with my own career search which resulted in a position that exceeded my expectations."
    - Jeff Knight, PhD -  Vice President, Clinical Operations, Halozyme Therapeutics