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Associate Director, Pharmacovigilance Science, Hematology-Oncology

Req #: 17001636
Location: Summit, NJ US
Job Category: Medical
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Director
Travel: Yes, 10 % of the Time
Other Locations:US- NJ- Summit East

Responsible for ensuring proactive signal detection and management, and provision of safety analytical support to the Lead Product Safety Physician (LPSP). Key purpose include drafting safety and regulatory documents and ensuring consistency of safety messages.

Key Activities:

Signal Detection, Validation and Risk Mitigation

Analyze and adjudicate data from signal detection outputs from both internal

and external databases to identify trends and potential safety signals

Draft safety signal monitoring reports (SSMR)

Evaluate scientific literature to identify potential safety signals

Coordinate actions and synthesize key safety information for signal validation

Manage signal evaluation from identification to risk mitigation and maintain signal tracker

Author safety topic reviews including literature search to identify background

information and rates, analysis and synthesis of safety data, and conclusion

Propose next steps for risk mitigation of validated signals

Draft CCDS revision and safety sections of regulatory submissions related to validated signals

Coordinate with Regulatory Operations the review and approval of key safety

documents through document management system

Strategize and collaborate with Risk Management and Regulatory Affairs to

develop documents to support risk mitigation

Update/maintain the Events of Interest work aid for Case Management

Develop follow up questions for Events of Interest

Governance

      Product Safety Review Meetings (PSRM)

Coordinate and conduct quarterly intra-department meetings

Draft and distribute agenda and meeting minutes with action items

Produce slide decks

Present overviews of aggregate reports

Present findings from safety topic reviews and other safety related information

Track action items

      Safety Management Team (SMT) Meetings

Coordinate quarterly and ad hoc SMT meetings

Produce slide decks

Present overviews of aggregate reports

Present findings from safety topic reviews and other safety related information

Track action items

      Company Safety Committee (CSC) Meetings

Develop materials for CSC meetings

Labeling Working Group Participation

Analyze post-market data and draft corresponding safety sections of CCDS

Collaborate with labeling team and TSS to support the inclusion of safety

information by analyzing safety data from clinical trials and IITs

Support the development of safety sections of regional labeling, as needed

Aggregate Reports

Identify literature to be included in aggregate reports

Author and/or contribute assigned sections

Review and comment as delegated by LPSP

Issues/Crisis Management        

Collaborate with LPSP, Regulatory Affairs, Regulatory

Operations and other functional areas as needed to address urgent safety queries.

Analyze and synthesize safety data

Draft relevant safety sections of the response

Collaborate with and support other Safety Scientists as needed

Execute issue management plan

Support communication planning

Literature           

Evaluate literature for potential safety signals and impact on risk-benefit

QC disposition of literature articles in SLD quarterly

Publications      

Identify, in collaboration with LPSP, Medical Affairs and or

Scientific Communications, publication needs

Develop and manage project plan in collaboration with Scientific Communications

Strategize and identify data needs

Draft outline

Analyze data

Draft, review and approve abstracts/articles/posters

Review, comment and/or approve publications related to assigned product(s)

Procedures        

Review and comment on SOPs/WPs pertinent to key activities

Training

Train and mentor new Safety Scientists

Output/Deliverables:

Signal detection reports

Signal tracker

Safety topic reviews

Safety sections of regulatory labeling and submission documents

Meeting minutes and presentation slides

Events of Interest work aid

Risk/signal sections (reviewed or written sections) to aggregate report documents

Orientation plans, training materials

SOPs, WPs

Templates for safety documents, as applicable

Responses to inspection, audit, QC process/findings, as applicable

Competencies:

Ability to analyze, interpret and clearly present scientific and technical data (oral and written)

Decision making

Scientific leadership

Critical thinking

Organization and planning

Communication skills

Teamwork; ability to thrive in a global matrix environment

Ability to work with minimal supervision; exercise judgment on matters that require further input from others vs. not

Proficiency in computer applications such as ARISg, Business Objects/Business Intelligence, Empirica

Proficiency in MedDRA coding and SMQ use

Qualifications/ Experience:

Nursing degree (e.g., BSN, MS) preferred, Pharmacy (PharmD) or other degree with the equivalent combination of relevant education and professional experience

At least 5 years of relevant clinical experience (with patient interaction), including training

Ten years of biotech/pharma experience of which five years in pharmacovigilance is a MUST.

Knowledge of signal recognition and statistical techniques

Assessment, interpretation & presentation of aggregate safety data

Knowledge of commercial drug environment

Knowledge of issues/crisis management

Clinical knowledge of therapeutic area patient populations and drug class

Experience with safety-related risk management, in particular signal confirmation, health hazard

assessments, and risk mitigation

Mastery of global regulations and guidances

Mastery of industry principles of drug safety, drug development, pharmacology, biostatistics and pharmacoepidemiology

Mastery of safety data capture in pre- and post-marketing settings

Mastery of MedDRA Medical Coding principles

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