Associate Director, Pharmacovigilance Operations

Job Description

Position Summary:
Join Deciphera Pharmaceuticals as an Associate Director, Pharmacovigilance Operations. Lead and oversee adverse event case management, support study teams, maintain the drug safety database, and collaborate on risk management for clinical trials and post-marketing. Report to the Director, Pharmacovigilance Operations.

Key Responsibilities:

• Oversee vendor case processing and compliance.
• Establish and monitor CRO/vendor KPIs.
• Support the oversight and management of global safety data exchange agreements.
• Develop and maintain safety documents including Safety Management Plans, SOPs etc.
• Collaborate with other departments such as Regulatory Affairs, Quality Assurance, Clinical operations, Data management etc.
• Maintain knowledge and compliance to current regulatory safety reporting guidelines
• Participate in audits and regulatory inspections.
• Provide technical support entering and retrieving information from the safety database.
• Support budget planning and trend analysis.
• Assist in implementation and management of GVP/GCP quality programs.
• Manages, assist and/or conduct external site and vendor audits.
• Provide input on GVP Corrective and Preventive Action plans.
• Train employees on safety reporting responsibilities.

Qualifications

• PhD or equivalent plus 5+ years of experience or Bachelors or Masters plus 10+ years of experience
• Strong managerial and communication skills.
• Knowledge of US and ex-US pharmacovigilance regulations.
• Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (i.e. eTMF, EDC, Argus, ArisG etc)
• Experience with overseeing and managing vendors
• Familiarity with MedDRA, WHO Drug dictionaries, and safety database programs.

• Experience in pre- and post-approval pharmacovigilance activities.
• Proficiency in standard computer software (Word, Excel, PowerPoint).

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.