Lead Pharmacovigilance Manager

2 weeks ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Position Overview:
As a key player in the Pharmacovigilance and Risk Management team, the Senior Manager will engage in critical medical and data analysis for assigned investigational and marketed products. This role demands a balance of independent initiative and collaborative teamwork.

Key Responsibilities:
1. Act as the analytical safety lead for designated programs/products.
2. Oversee signal management, which includes detection, investigation, and the preparation of comprehensive evaluation reports.
3. Review and interpret data outputs and literature, effectively communicating findings.
4. Analyze data for aggregate safety reports and respond to regulatory inquiries.
5. Support activities related to Risk Management Plans (RMP).
6. Participate in regulatory submission processes and assist with ad-hoc queries from health authorities.

Qualifications:
- A minimum of 6 years of relevant experience in medical, scientific, clinical, or pharmaceutical fields, with at least 2 years in drug safety.
- Advanced degree (PharmD, MD, PhD, MPH, NP, MS) is required.
- Proven experience in analyzing and interpreting medical and scientific data.
- Strong understanding of research methodologies and epidemiological principles is advantageous.
- Familiarity with pharmacovigilance regulations and drug development processes is essential.
- Proficiency in Microsoft Office Suite and Argus Safety systems; knowledge of statistical software is a plus.

Core Values:
Deciphera is dedicated to enhancing the lives of cancer patients, emphasizing accountability, transparency, honesty, and stewardship in all operations. We strive to foster a culture that values diversity and encourages personal and professional growth.

Benefits:
Deciphera offers a comprehensive benefits package, including:
- Non-accrual paid time off
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Generous parental leave
- Flexible spending accounts
- Family planning benefits
- And more.

We are committed to equal employment opportunities and value diversity in our workforce.

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