Pfizer Drug Safety/Pharmacovigilance Sr. Director (Disease Area Cluster Lead), Oncology in New York, New York
• Manages one or more SSRM DA-Clusters (Safety Surveillance and Risk Management, Disease Area)
• Supervises the Safety Risk Leads (SRL) globally in the SSRM DA-Cluster; SRLs are the
product "safety-management-team" (e.g. Risk Management Committee) chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs.
• Ensures that advanced SS & RM in SSRM is affected productively. Oversees and performs proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
• Supports the SRLs with their responsibility of acting as a Safety Point of Contact to the Asset Teams, ensuring a unified communication on safety matters for WWS
• May perform the role of senior SRLs when needed
Responsibilities • Manages Safety Risk Leads (SRLs) globally as necessary to support SSRM DA-Cluster deliverables. SSRM-DA-Head may manage more than one DA or DA-Cluster. The SSRM DALead's reports may be located locally or globally (remote).
• Integral participating member of the SSRM-LT. May represent VP-SSRM-Head in local site WWS management and operational matters. Engages collaboratively with WWS leadership and functions.
• Supervises the SSRM DA staff globally in their performing proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
• Ensures that advanced SS & RM in SSRM is affected productively.
• Effectively communicates resource, timeline and other DA-Cluster and Product issues as appropriate to the VP, SSRM BU/RU Group Head.
• SSRM-DA-Cluster Lead position supports the role of the SRLs, acting as both a manager and also as an individual contributor (senior SRL) performing senior SRL responsibilities
• The SSRM-DA-Cluster Lead directly contributes to:
Enabling WWS pan-BU prioritization of resources, rapid re-deployment/refill/dual deployment.
Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence inlicensing assessments
Assigning the "right colleague to the right project at the right time"
SSRM providing consistent direct line Management of the colleague matrix supporting all BUs
Opportunity for colleagues' development into areas of expertise and growth in what they "do best", applicable to any BU
Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
Appropriate development and training of SSRM colleagues, to provide consistently robust SS & RM activities in the BUs
Broad platform on which to determine WWS (partner/platform) service costs (SLA) to BUs
Identifying opportunities for Consistency and Standards for SS & RM approaches and
processes within a DA-Cluster and across BUs, and supporting the piloting and implementation
Qualifications MD or equivalent, and appropriate Pharma experience in SS & RM (see also SRL Role
• Managerial/Supervisory experience or related experience is a usual requirement.
• DA-specific knowledge is helpful.
• Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
• Thorough understanding of safety Risk Management internal and external environment, including applicable regulations and guidances. Comprehensive knowledge of drug development process. Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
• Ability in, and track record of, working effectively in an advanced matrix structure including matrix team leadership/representation.
• Excellent verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Knowledge, skills and ability in report's roles (All requirements of the senior Safety Risk Lead (SRL) roles (see SRL role description in WWS SSRM)).
Skills, (plus knowledge, experience and ability in):
• Leadership, project management, resource management, administrative, and technical capabilities are required.
• Displays both line and matrix management skills, locally and globally (remotely).
• Forward planning and anticipation of the needs of the individual and the DA-Cluster.
• Motivates colleagues through example, commitment, loyalty and enthusiasm. Utilizes and encourages innovative approaches to build and maintain SS & RM advantage. Influences Internal and external stakeholders to build the reputation of the SSRM DA- Cluster.
• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-today activities.
• Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues' diverse opinions and bringing group to consensus. Next steps and actions are clear.
• Strong Matrix partnering, inclusiveness and collaborative working relationship with WSR colleagues, including Epidemiology Head and Leads and other colleagues supplying sources of safety information.
• Working effectively when co-located with, and when remote from, product teams/leaders/managers and reports.
• Championing high quality SSRM deliverables, and innovation.
• From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety sinals to the appropriate forums.
• Effective interactions with key external subject matter experts including regulatory authorities.
Additional Offer Details:
- Grade: 20 Additional Location Information: NY Headquarters, Groton, CT, Peapack, NJ, or Collegeville, PA.Eligible for Employee Referral Bonus
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