Senior Manager, Pharmacovigilance Operations

  • waltham
Company Description

All candidates should make sure to read the following job description and information carefully before applying.
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera's FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.
Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.
We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:
Patients - places the importance of improving the lives of patients and their caregivers at the forefront of every day's work.
Accountability - for our performance and the way we work with coworkers and other stakeholders.
Transparency - in our intent and actions to both internal and external stakeholders.
Honesty and Integrity - fosters trust and strives to deliver on our and the company's promises.
Stewardship - values and uses wisely the resources and investments provided to the company.
Job Description
The Senior Manager, 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 Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable).
What You'll Do:
Responsible for performing critical 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 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
Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor
Lead Deciphera Pharmaceuticals PV Operations in 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 Deciphera Pharmaceutical 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 the 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 reconciliation activities.
Develop and maintain Medical Safety and Pharmacovigilance related documents including Safety Management Plans, SOPs and Work Instructions, and Safety Data Exchange Agreements.
Lead preparation of safety-related plans with partners and CROs
Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Deciphera 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 needed with the 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 to ensure alignment among case handling, aggregate reporting, and signal detection activities
Assist with the ongoing review TFLs 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 of Deciphera Pharmaceutical 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
Other duties as assigned
Education: Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
6 - 8 years of direct pharmacovigilance work experience in the pharmaceutical industry
Experience with Argus Safety database is a must
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 including configuration and validation activities is
Additional Information
What Deciphera will Bring:
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:
Non-accrual paid time off
Summer vacation bonus
Global, company-wide summer and winter shutdowns
An annual lifestyle allowance
Monthly cell phone stipend
Internal rewards and recognition program
Munch and learns
Medical, Dental, and Vision Insurance
401(k) retirement plan
Life andSupplemental life insurance for family
ESPP offering
Health savings account
Flexible spending account for either health care and/or dependent care.
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.PDN-99ca3c5c-5439-4ffa-8e86-ec2f09e7f004