The PV Clinical Specialist supports the drug safety staff in the strategic and operational job responsibilities, 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 specialist is responsible for 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 Manager- Specialist in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Specialist.
Key Accountabilities (The E4 and E5 PV Clinical Specialists will perform some or all the following activities):
Functions as the subject matter expert for all types of case processing, provides guidance, and oversight of ICSR quality within PV Clinical Team
Provides strategic input on case processing activities performed by the PV support team
Performs trend analysis for ICSRs processed in global safety database
Provides feedback and escalates [if required] to PV clinical management of any trends observed
Assists senior PV specialists in performing enhanced follow up activities [as required]
Assists in case process related activities during audits and inspections
Demonstrates expertise of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
Demonstrates understanding of local and global health authority requirements pertaining to ICSR processing
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
Demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) in order to oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas
Accountable for providing PV oversight to appropriate study/molecule teams
Accountable for Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche sponsored and supported studies based on medical knowledge and European Union (EU) regulations
Reviews Safety Data Exchange Agreements and Safety Management Plans (as applicable)
Responsible for the assignment of molecule and therapeutic area assignments and tracking
Reviews Safety Data Exchange Agreements and Safety Management Plans and provides guidance on related documents (as applicable)
Actively participates as a member of the Study Management Team and performs PV activities including but not limited to: Providing presentations for investigator meetings, oversee clinical trial reconciliation and/or Case Transmission Verification (CTV) (as applicable), acts as a single point of contact for safety related concerns, and acts as a safety liaison between safety science, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies.
Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include
Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
Provides medical team molecule support in appropriate safety areas
Advises medical teams conducting interventional or non-interventional research that improves the care of patient from safety perspective
Independently oversees signal detection and validation for aggregate data received by USDS (e.g, PBRER, PSUR etc.)
Responsible for ensuring oversight and appropriate classification of all activities under USMA
Exhibits total knowledge of study classification (i.e, interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc.)
Communicates and updates Team of any process related issues/ concerns
Acts as single point of contact for safety related concerns
Acts as Safety Liaison between Safety Science and Medical Team.
Expert knowledge of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents
Provides guidance on the medical review of safety related documents, including but not limited to pregnancy letters and develop a plan of action to mitigate any risk
Prepares written responses to drug safety queries from Health Care Professionals using the locally available information and/or initiating literature searches as required and/or initiating an investigation by Drug Safety Contact Line (global) as needed
Responsible for implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products, with the ability to function as the RMP IC (as required)
Responsible for performing and overseeing health authority submissions via thorough understanding of FDA regulations as per code of Federal regulations (CFR)
Responsible for regular review of US submission rules within the safety database
Acts as a single point of contact for submission related inquiries
Liaises with internal/external stakeholders (i.e., PV information system, PDSS, regulatory, health authorities as applicable) to understand and implement regulatory requirements or any applicable changes
Develops, performs, and provides input on drug safety presentations for internal /external stakeholders as applicable.
Responsible for identifying any deviations or process improvements including corrective and preventive actions Contribute PV expertise to Genentech work products and coach/mentor others as needed
Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
Manages all PV related activities or commitments are appropriately actioned for assigned therapeutic areas which include but not limited to overseeing all study activities performed by individual molecule responsible
Participates in preparation on abstracts, posters, and presentation for medical/ scientific meeting and/or congresses based on the collaborative initiatives
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.
Works closely with PV Clinical Manager 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.
Provide support during audits and inspections.
Collaborates with PV Operations and SP PV Oversight teams as needed
E4 PV Clinical Specialists
The PV Clinical Specialists demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to oversee and lead the protocol review process for supported/funded studies for molecules/products in assigned therapeutic areas under limited direct from the PV Clinical Specialist Manager. PV Clinical Specialist also provides guidance to PV Clinical Support staff as needed. Accountable for providing PV oversight to appropriate study/molecule teams and for activities concerning SRT or other similar governing bodies
E5 Senior PV Clinical Specialists - Expert in all PV Clinical Specialist activities in addition to the following:
Demonstrates expert knowledge of all PV clinical related activities and provides guidance to PV Clinical Specialist and support staff. Is also primarily responsible for all sponsored studies and medical team (or similar governing bodies) related activities.
Provides strategic input in collaboration with the PV Clinical Managers / PV Clinical Head and can work independently within PV Clinical activities. Acts as an expert on Health Authority Regulations and supports PV Clinical Managers with interpretation of these regulations. Takes accountability for cross-functional projects and achieves desired results with minimal supervision. Identifies process improvements, establishes new standards and techniques to improve PV standards and compliance as required.
Competencies Identified for Success:
Demonstrates capability to comprehend, and analyze medical information
Works effectively, independently and collaboratively
Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
Demonstrates ownership, initiative, accountability, and the ability to manage change
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
Education, Experience, and Other Requirements:
Health Care Professional bachelor degree with strong academic background (e.g. RN/BSN/MSN, NP, RPh/ PharmD/ B.Pharm or MD) (Required)
Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred)
Able to travel as per business needs
1-3 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)
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
Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development
Considerable experience in the principles
Proven track record of meeting or exceeding objectives and goals
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