Job Description
This position is accountable for clinical trial and post marketing medical review of cases in PV operations and a major contributor for planned PV operations activities at Pharmacyclics.
Key Accountabilities/Core Job Responsibilities
Medical review of assigned cases both from post-market and clinical trials activities.
As the PV alliances lead, manage relationships with other functions within Pharmacyclics, business partners and safety vendors.
Directly supervise the assigned staff and PV vendor(s) to ensure appropriate adverse event data collection, processing and regulatory reporting in accordance with global safety regulations.
Oversight of communication between Pharmacyclics and business partners including representing PCYC at working groups and meetings.
Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for clinical trials, as needed.
Responsible for development and maintenance of and adherence to SDEAs, PVAs, Site Letters, and Safety Exchange documents, as well as Safety Team Charters.
Provide guidance for safety reporting sections of clinical documents, including the review and approval of the safety portion of protocols, reports and other documents, as needed.
Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes as needed .
Develop and maintain policies and procedures for safety/pharmacovigilance activities worldwide.
Provide expert guidance on global regulations, and industry guidelines and their impact on Safety management processes and procedures.
Performs other duties as requested.
Qualifications
General knowledge of pharmaceutical development and a minimum of 5+ years of related experience in safety operations.
MD degree.
Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Must be self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work
Must be able to develop business solutions to complex problems
Must have strong interpersonal/organizational skills as well as a team oriented approach
Experience with preparation of investigational and post-marketing regulatory reports
Proficiency in standard desktop software programs (Word, Excel, Outlook, PowerPoint)
Experience using Argus Safety or other safety database applications
Experience using MedDRA and WHO dictionaries
Required Skills
Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
Outstanding communication skills (verbal and written).
Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
Strong project management and effective negotiation skills required
Must be able to exercise independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
This position is accountable for clinical trial and post marketing medical review of cases in PV operations and a major contributor for planned PV operations activities at Pharmacyclics.
Key Accountabilities/Core Job Responsibilities
Medical review of assigned cases both from post-market and clinical trials activities.
As the PV alliances lead, manage relationships with other functions within Pharmacyclics, business partners and safety vendors.
Directly supervise the assigned staff and PV vendor(s) to ensure appropriate adverse event data collection, processing and regulatory reporting in accordance with global safety regulations.
Oversight of communication between Pharmacyclics and business partners including representing PCYC at working groups and meetings.
Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for clinical trials, as needed.
Responsible for development and maintenance of and adherence to SDEAs, PVAs, Site Letters, and Safety Exchange documents, as well as Safety Team Charters.
Provide guidance for safety reporting sections of clinical documents, including the review and approval of the safety portion of protocols, reports and other documents, as needed.
Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes as needed .
Develop and maintain policies and procedures for safety/pharmacovigilance activities worldwide.
Provide expert guidance on global regulations, and industry guidelines and their impact on Safety management processes and procedures.
Performs other duties as requested.
Qualifications
General knowledge of pharmaceutical development and a minimum of 5+ years of related experience in safety operations.
MD degree.
Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Must be self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work
Must be able to develop business solutions to complex problems
Must have strong interpersonal/organizational skills as well as a team oriented approach
Experience with preparation of investigational and post-marketing regulatory reports
Proficiency in standard desktop software programs (Word, Excel, Outlook, PowerPoint)
Experience using Argus Safety or other safety database applications
Experience using MedDRA and WHO dictionaries
Required Skills
Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
Outstanding communication skills (verbal and written).
Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
Strong project management and effective negotiation skills required
Must be able to exercise independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
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