Description

Position summary:

The Sr. Manager/Associate, Drug Safety and Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all of Invivyd's Clinical Trials and post marketing.

Requirements

Responsibilities:  

• Responsible for performing day-to-day safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
• Review incoming adverse events to determine action required
• Provide oversight and quality review of vendor case processing and submission activities by external vendor, including the review and monitoring of compliance through various monitoring reports and other oversight activities. Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database
• Prepare and present departmental metrics at monthly departmental meetings
• Responsible for facilitation of training, including training GVP Modules and key relevant US & global (i.e. EMA) safety-related Guidance documents and procedures
• Training and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor
• Responsible for ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner. Manage SAE / SUSAR reporting activities for all investigational drugs
• Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements
• Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from clinical trials
• Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance to data requests. Performing and contributing to safety monitoring and signal detection activities for products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks. Perform ad hoc analyses as required
• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements
• Support oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
• Communicates with partner companies and vendors regarding processing and timely exchange of safety data.
• Distributes aggregate reports as required and assists with safety-related reconciliation activities.
• Provide vendor oversight and management for all outsourced or insourced PV activities and from set up of the vendor relationships vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight/ safety management plans) to ensure inspection-ready documentation of oversight
• Develop and maintain Medical Safety and Pharmacovigilance related documents including Safety Management Plans, SOPs and Work Instructions, and Safety Data Exchange Agreements.
• Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Invivyd practices and procedures.
• Contribute to preparation of relevant safety sections of Clinical Study Reports, Annual Reports, Expedited Safety Reports and other regulatory filing documents
• Assist, as required, with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc.
• Assist with response to safety-related queries from Regulatory Authorities or Ethics Committees, if needed
• Collaborate wih external vendors and internal stakeholders to ensure alignment among case handling, aggregate reporting, and signal detection activities
• Assist with the ongoing review Tables, Listings and Figures (TLFs) and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
• Support the development and optimization of Invivyd Therapeutics PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
• Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
• Adhere to company policies and applicable regulations including reporting of adverse events to regulatory agencies
• Authors case processing data entry guidelines, work instructions, and other guidance’s.
• Reviews/authors aggregate reports ( as needed (i.e. Safety Management Plan, Data Management Plan, Medical Monitoring Plan, etc).
• Performs Safety surveillance and signal detection/evaluation activities with oversight of Head of PV or lead MD
• Supports authoring of aggregate reports (i.e. DSUR, PADER).
• Leads PV portion of presentations to external stakeholders (iDMC, etc).
• Participates in internal Safety governance activities.
• Participates in cross functional meetings as necessary.
• Ensures compliance with ICSR reportability timelines.
• Supports vendor selection through participation in bid defenses, review of scopes of work, etc.
• Other duties as assigned
  

Requirements: 

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.) Clinical experience preferred
• A minimum 8 years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company, with at least 6 years hands on experience in adverse event case management is required
• Experience with software-based drug safety systems (ARIS-G and/or ARGUS experience) is required
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
• ICSR submission experience is highly preferred
• Knowledge of MedDRA and WHO Drug dictionaries
• Experience with overseeing and managing vendors
• Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
• Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data
• Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
• Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects.
• Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Proficient in standard computer software (Word, Excel and Power point presentations)
• Previous experience and formal training with safety database programs