Summary of Position:
The PV Clinical Manager - Specialist is responsible for the leadership and management of the strategic and operational job activities in PV Clinical, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Manager - specialist manages the oversight of study related activities in collaboration with other functional groups, serves as the single point of contact with Pharma Development Safety Science, and supports the US Drug Safety PV Clinical Head in all activities. All responsibilities are performed under the direction of the PV Clinical Head.
The PV Clinical Manager – Specialist demonstrates high level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs).
· Manages the subject matter expert for all types of case processing, provides guidance, and oversight of ICSR quality within PV Clinical Team
· Responsible for maintaining compliance with health authority regulations and guidance documents pertaining to ICSR submissions
· Responsible for the oversight and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS) and external collaborations agreements, e.g. PVAs and SDEAs
· Responsible for the oversight of identifying, creating additional, or updating existing local Guidance Documents including but not limited to training matrix, identify appropriate target audience for training assignment
· Accountable for all study related activities under the scope of USDS within USMA/Genentech
· Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
· Participates in preparation on abstracts, posters, and presentation for medical/ scientific meeting and/or congresses based on the collaborative initiatives
· Able to effectively demonstrate strong leadership across all PV Clinical related activities across all therapeutic areas and extensive breath of knowledge of key stakeholders external to USDS.
· Provides routine oversight of US Drug Safety-related activities for all products in the Genentech/ Roche portfolio under the direction of Head, PV Clinical.
· Demonstrates understanding of appropriate labeling documents of Genentech/ Roche molecules and products.
· Accountable for the design and implementation of strategic, operational and personnel plans for assigned US Drug Safety-related activities to include the intake and submission of spontaneous reports as well as safety support and direction for US Medical Affairs sponsored and supported interventional and non-interventional studies and programs
· Leads in the creation of both local and global organizational strategies, goals, and objectives for the department, and plays a key role in the implementation of these activities (e.g., rollout of new safety initiatives, implementation of new Health Authority safety requirements)
· Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
· Maintains strong relationships with Global Safety and other Affiliates to address safety queries, share best practices, and discuss new safety regulations
· Reviews local PV agreements, as required.
· Responsible for providing strategic input into ICSR activities, applicable safety commitments for all licensing partners, clinical reviews, PBRER reviews, enhanced phone follow up, and molecule support for medical teams
· Assists in the review, comment and approval of US Periodic Reports on behalf of USDS
· Assists in the implementation, coordination, and tracking of US Risk Management Plans, as applicable and as assigned
· Accountable for coaching and developing direct reports by providing an environment that encourages ongoing personal and professional development
· Responsible for the performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for the role
· Responsible for the identification of talent to be developed into potential succession candidates.
· Acts as a mentor for the Managers of PV Clinical Support
· Acts as single point of contact with key stakeholders for safety related activities and acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs (when required)
· Works closely with PV Clinical Managers to be aware of any safety issues / concerns and assist or leads special projects as assigned by and under the direction of the US Drug Safety PV Clinical Manager and/or other Safety personnel.
· Collaborates with PV Operations and SP PV Oversight teams as needed and provide support during audits and inspection
Competencies Identified for Success:
· Displays a high level of commitment.
· Generates enthusiasm and drive for commitment to excellence.
· Demonstrates strong ability to lead effectively and drive optimal outcome
· Strong customer orientation/focus
· Ability to flex and thrive in an agile and fast changing environment
· Works well independent or within teams and is effective in collaborating with others internally and externally
· Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data
· Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
· Ability to effectively and efficiently manage multiple priorities
· Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
· Good negotiation skills: can drive discussions and decisions towards desired results
· Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities
· Strong attention-to-detail
Education, Experience, and Other Requirements:
· Health Care Professional (HCP) or individuals with Master's degree with relevant pharmaceutical industry experience in Pharmacovigilance.
· Minimum of 6 years recent experience in the pharmaceutical industry. Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. Knowledge of EMEA regulations preferred.
· Minimum of 2 years experience in supervisory role preferably in a comparable drug safety organization.
· Computer proficiency and data entry experience (Preferred).
· Strong academic background preferred
· Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development
· Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, medical writing
· Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred
· Proven track record of meeting or exceeding objectives and goals
· Previous people management experience is preferred; Demonstrated ability to coach, mentor and develop emerging leaders
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.