Job Description

Company Description

Job Description

We are seeking a Medical Director to report to the Senior Medical Director of Pharmacovigilance, based in the Waltham office.

The Medical Director will oversee global pharmacovigilance for marketed and investigational products, including safety data review, signal detection, benefit-risk management, and communication with upper management. The role may also involve representing Deciphera at meetings and serving as the Safety lead for specific products.

The ideal candidate will be adaptable, capable of working independently in a dynamic environment, and experienced in interacting with various management levels.

What You'll Do:

1. Lead and oversee safety surveillance and risk management activities for assigned products.
2. Provide pharmacovigilance expertise for decision-making based on data analysis and risk assessment.
3. Review and assess adverse event reports, ensuring quality and consistency.
4. Support cross-functional teams on safety-related protocol issues and development documents.
5. Participate in safety reviews, meetings, inspections, and audits.
6. Train team members and vendors on safety and medical review processes.
7. Contribute to safety reports, regulatory documents, and responses.
8. Collaborate with regulatory and other teams on safety issues and risk management plans.
9. Present safety data at safety committee meetings and contribute to safety-related documentation.
10. Support inspections, audits, and on-site activities as needed.

Qualifications:

• Degree in health sciences or related field; relevant training or experience mandatory.
• At least 3 years of clinical operations experience in pharma or CRO.
• Proficiency with relevant software and systems.
• Thorough knowledge of regulatory guidelines and GCPs.
• Strong communication and management skills.

Additional Information:

Base salary ranges from $228,000 to $313,000, depending on experience and location. Deciphera offers comprehensive benefits, including bonuses, retirement plans, health insurance, parental leave, and growth opportunities.

Apply Now:

Join us in our mission to improve lives. Apply today!

Equal Employment Opportunity:

Deciphera values diversity and is committed to fair employment practices. Completion of a confidential survey is optional and will not affect employment opportunities.

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