Senior Director, Pharmacovigilance Sciences Lead
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Role Summary:
The Senior Director Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio.
The Senior Director Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct activities such as signal management aggregate reports RMP development ad hoc safety query responses literature surveillance and safety analyses for regulatory submissions (NDA MAA etc.) and contributions to key documents (IB/RSIs ICFs SMPs DMC materials coding reviews and safety analyses for CSRs as applicable). The Senior Director Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives strategic innovations and team leadership.
Key Responsibilities:
- Oversees PV Sciences deliverables across the portfolio 50%
- Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations including:
- Signal detection evaluation and management
- Aggregate safety reports (DSURs PADERs PBRERs)
- Risk management plans (including maintenance and implementation of risk minimization measures)
- Literature surveillance
- Safety governance meeting preparation and documentation
- Safety-related regulatory query responses
- Safety-related contributions to key documents (IB/RSIs CCDS/labels ICF etc.)
- Contributions to safety analyses associated with regulatory filings (e.g. New Drug Applications or Marketing Authorisation Applications)
- Inspection preparation and execution
- Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations including:
- Strategic leadership management and mentorship 50%
- Sets strategy for the PV Sciences team aligning with corporate goals and safety objectives and ensures that relevant goals are met
- Leads recruitment mentoring career development and performance management of PV Sciences team
- Collaborate with cross-functional teams such as Clinical Development Regulatory Affairs Quality Medical Affairs and other relevant functions to maintain integrated safety oversight.
- Leads process improvements and conducts impact assessments
- Ensures appropriate training and individual development for direct and indirect reports
- Other duties and responsibilities as assigned
Qualifications :
Required Qualifications:
- PhD or equivalent plus 10 years of experience or Bachelors or Masters plus 15 years of experience in a PV scientist role.
- Demonstrated experience in analysis and interpretation of medical and scientific data including experience in both post-marketing and clinical trials
- Excellent oral and written communication skills including the ability to effectively communicate with senior leadership
- Detail-oriented with ability to think critically prioritize tasks and function independently
- Expert knowledge of pharmacovigilance and drug development including knowledge of applicable clinical trial and post-marketing safety regulations
- Proven track record in preparing and reviewing regulatory safety documents including NDAs/MAAs and RMPs
- Prior experience serving as an SME in audits and/or inspections
Preferred Capabilities:
- Demonstrated experience in the oncology therapeutic area
- Expert proficiency with pharmacovigilance databases and relevant coding dictionaries
- Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems.
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $247000 - $340000. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- FDA Regulations
- Management Experience
- Manufacturing & Controls
- Biotechnology
- Clinical Development
- Clinical Trials
- Drug Discovery
- Project Management
- Filing
- Team Management
- Leadership Experience
- Chemistry
