Manager, Drug Safety Physician

General

• Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
• Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Communicating and discussing issues related to review process with
• Line Manager/ Project Leader/Designee
• Interacting with internal and external stakeholders for resolving issues
• Attending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)
• Assisting the Project Lead/Functional Lead for audits and inspections
• Provides inputs for process improvements
• Works closely with Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
• Function as pharmacovigilance representative/safety scientist
• Attend/support Bid defense meetings
• Contribute to assigned Therapeutic Area and actively support development of scientific & medical expertise
• Mentoring of Drug Safety physicians

Case reportmedical review (as applicable)

• Performing medical review of cases not limited to (including non-serious
• and serious spontaneous (including legal cases), clinical trial, and
• literature cases including combination products {drug-device}) according
• to client/Parexel Standard Operating Procedures (SOPs; as applicable)
• and liaising with the client, as required
• Writing Pharmacovigilance/Marketing Authorization Holder (MAH)
• comment and assessing company causality
• Review appropriateness of medical content in narrative for medical
• coherence
• Assessing seriousness, listedness / expectedness of reported events.
• Providing medical inputs to case processing team
• Raising appropriate follow-up queries for relevant information from the
• reporter/HCP (Health Care Professional)
• Review and verify appropriate selection of adverse events from source
• documents, assign appropriate Medical Dictionary for Regulatory
• Activities (MedDRA) code, review narrative
• Identify and resolve case issues, coordinate with client therapeutic/legal Team

Medical monitoring (as applicable)

• Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed
• Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities
• Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
• Provide medical safety expertise to client per request
• Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities
• Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety
• Review coding of adverse events, medical history and concomitant medications for accuracy and consistency
• Review of patient profile report as needed
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or iconjunction with other Parexel departments
• Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings)

Literature Review (As applicable)

• Review of literature for product safety assessment and potential safety issues
• Expert in reviewing literature references including triaging, summarizing and providing MAH comments for aggregate reports and for various signal management activities

CSR Narratives (as applicable)

• Performing medical review of Clinical study report narratives according to the client’s guidelines and SOPs
• Provide medical guidance to PV team/study team
• Provide medical guidance to safety staff during the case processing cycle
• Provide input as necessary to Feasibility Studies, Data Monitoring
• Committees (DMCs), Clinical Endpoint Committees (CECs)
• Provide medical input into Pharmacovigilance workflows and projects as required
• On an as-needed basis, provide support in mentoring or training of new hired physicians

Line Management

• Supervise and mentor direct reports, including all aspects of personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, teambuilding, morale, motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations
• Provide guidance to the team to ensure their performance meets or exceeds both the business and their own personal goals/objectives
• Oversee execution of core deliverables
• Maintain a strong familiarity with Parexel and client systems and related processes
• Represent Parexel in the project meetings
• Ensure communication of important decisions/policies discussed with higher management to the team members
• Act as a Subject Matter Expert during Audits/inspections
• Identifying and addressing any inter-personal issues within the team
• Holding regular team meetings, identifying any areas of concern within the team and escalating these to the higher management, if required
• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall program
• Continuously monitor overall project performance, KPIs, and, if necessary, identify ways to ensure that the project is completed on-time and within budget
• Keep client and team informed of project status
• Propose creative solutions for shifting timelines and staffing requirements to the management
• Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated
• Proactively manage, communicate and escalate as appropriate, potential safety signals associated with marketed products to the relevant stakeholders
• Project Management/Leadership
• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall program
• Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget
• Keep client and team informed of project status
• Propose creative solutions for shifting timelines and staffing requirements to the management
• Fulfill Subject Matter Expertise role for various topics, depending on experience
• Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated
• Be familiar with all required SOPs and guidelines, and provide input into regular review of these documents, as applicable
• Attend external audits as required; respond to audit reports and follow up on any issues highlighted

Quality and Compliance

• Strive to ensure internal and external clients receive the required deliverable within stipulated timelines
• Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines

Skills:

• Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
• Good knowledge of drug safety and the drug development process
• Good presentation and verbal/written communication skills
• Good interpersonal skills
• Client focused approach to work
• Computer proficiency, an ability to work with web-based applications and familiarity with the
• Windows operating system and Microsoft Office apps
• An ability to comprehend various regulatory or client requests and be able to strategize a handling approach
• A flexible attitude with respect to work assignments and new learnings
• An ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• An ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
• A willingness to work in a matrix environment and to value the importance of teamwork
• Strong knowledge of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines

Knowledge and Experience:

A minimum of 6 Years experience in Pharmacovigilance/Drug Safety with at least 2 years of experience in people management role.

Good knowledge/understanding of medical terminology