Deciphera Pharmaceuticals
Senior Director, Pharmacovigilance Sciences Lead
Deciphera Pharmaceuticals, Waltham, Massachusetts, United States, 02254
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
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
Collaborates 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 $247,000 - $340,000. 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 Deciphera's 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.
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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
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
Collaborates 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 $247,000 - $340,000. 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 Deciphera's 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.
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