Senior Medical Director - Pharmacovigilance/Drug Safety

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Job Purpose

The Senior Medical Director is responsible for providing leadership and directions to the Safety Medical Sciences business functions and other assigned business functions, as well as provide strategic inputs to Safety Services Leadership.

The Senior Medical Director is also responsible for implementation of suitable technology and innovations for the function and acts as Business Owner of related systems and Process Owner for applicable SOPs.

You will also:

• Represent function/department at various internal and external forums.

• Contribute significantly to thought leadership activities.

• Responsible for resource management, overall quality, business continuity, utilization and profitability.

Key Accountabilities

• Maintaining an excellent 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 excellent awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

• Attending, proving consultations and/or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)

• Overall responsible for quality of the function and function’s Key Performance Indicators (KPIs) targets

• Works in collaboration with Safety Services Leadership Team and provide strategic and competitive inputs to the department and organization

• 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 and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

• Reviewing and/or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs

• Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness

• Review and sign off Data Management line listings

• Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).

• Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities.

• Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness

• Author/review responses to HA requests and other safety documents

• Medical Writers (MWs) authoring SERs, Signal validations etc.

• Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)

• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues

• Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs

• Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)

• Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents 

• Contribute to regulatory agency submissions (Investigational new drug applications, New drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages

• Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable

• Therapeutic Area Head (TAH) provides PV expertise, leadership, mentorship, and supervision of involved Therapeutic Area members and personnel assigned to the respective organization to ensure appropriate assessment of Safety information related to assigned products/portfolio

• TAH oversees compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables which include Scheduled Reports, Ad Hoc Reports and Signal Management. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents

• Management of Safety Officers, Signal Management Expert(s), Risk Management Expert(s), PV Scientist(s) and administrative assistants

• Ensure alignment of Therapeutic Area objectives, safety strategies and issue escalation with PV

• Oversee continuous evaluation of safety and benefit risk assessment activities and strategies for the Therapeutic Area

• Support for other therapeutic area teams and deputize for the PV Head if required
  

Knowledge and Experience:

• Extensive drug safety and clinical trial knowledge and experience

• Clinical practice experience

• Managerial and Leadership experience a must

• Very strong knowledge/understanding of medical terminology
  

Education:

• Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School

• Completion of at least a basic training in clinical medicine (residency, internship etc.)