Director, Pharmacovigilance Operations
1 month ago
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director, Pharmacovigilance Operations you will report to the Head of PV and Safety and be involved in all related operational activities of product safety surveillance and ensure the safety of product development. The Director, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department. This role will include support for development of the safety/PV department, support and management of internal and external PV stakeholders, development and oversight of PV CRO functions and compliance for the SMP (safety management plan), adverse event case management, aggregate report development and submissions, SOP, WI's, document guidance and form development, support of the signal detection/risk management of safety data for clinical trials and post marketing (where applicable), CAPA and quality oversight, support of audits and inspections and partner management (when applicable).
Cool stuff
What you'll do
Management of external shareholders, license partners and vendors. Development and implementation of pharmacovigilance agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) as well as monitoring compliance to the mentioned PVAs and SDEAs.
Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
Provide oversight and review of vendor case processing and submission activities
Review and monitoring of CRO compliance through various monitoring reports and other oversight activities such as tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database
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) and post marketing cases when applicable
Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events
Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance with data requests.
Manage SAE reconciliation process with internal and external partners
Assist in development, review and approval of search strategies for literature review
Contribute and support safety monitoring and signal detection activities for products including overseeing report scheduling and deliverables for signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks.
Support PSRT (program safety review team) quarterly and ad hoc analyses meetings including recording and approval of minutes.
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.
Oversees distribution of aggregate reports as required and assists with reconciliation activities if needed.
Develop and maintain Safety and Pharmacovigilance related documents including CRO Safety Management Plans, SOPs and Work Instructions, ESRP (PV expedited and periodic safety reporting plan) and Safety Data Exchange Agreements.
Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
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
Support the development of PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
Responsible for SOP development and facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
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
Serve as member of PV QA team with support for external and internal audits and inspections
What we're looking for
BSN, PharmD or similar related scientific background
10+ years of directly related experience in Pharmacovigilance
Experience working with and overseeing vendors and partners
Proven history of successful interaction with internal and external stakeholders
Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
Experience completing successful PV data migrations is a plus
What will separate you from the crowd
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
Experience with safety database systems (ARGUS, Aris G)
Proficient in standard computer software (Word, Excel and Power point presentations)
What you should know
The base pay range for this position at commencement of employment is expected to be between $210,000 to $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
We have other current jobs related to this field that you can find below
-
Senior Director, Pharmacovigilance
2 days ago
Cambridge, Massachusetts, United States Nimbus Therapeutics Full timeNimbus has an outstanding opportunity for an exceptional Senior Director of Pharmacovigilance to join our team. This physician leader shall have strategic and hands-on responsibility for clinical drug safety, particular within the therapeutic area of Oncology. Broad drug safety experience with small organic molecules is required to ensure monitoring,...
-
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Pharmacovigilance Scientist
1 week ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timePharmacovigilance Scientist - Contract - Fully remote role, Cambridge MAProclinical is seeking a dedicated Pharmacovigilance Scientist to join a Drug Safety team. Primary Responsibilities:This role will involve scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting. The successful candidate will also be responsible...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director, PV Operations Compliance, Alliance, and Process Excellence responsible for ensuring the highest level of complianceas part of Modernas Pharmacovigilance Quality Management System by providing oversight of commercial programs, establishing a framework for affiliate PV standards, and managing business continuity. This...
-
Senior Medical Director
2 weeks ago
Cambridge, Massachusetts, United States Repare Therapeutics Full timeReporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly early phase...
-
Director, Clinical Safety Scientist
3 weeks ago
Cambridge, Massachusetts, United States BioSpace Full timeJob DetailsThe Role:Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic safety input, daily support in clinical trial activities, perform trend analysis for signal management deliverables and safety analytical support for all Moderna products throughout the life-cycle.Heres What Youll...
-
Director, Safety Risk Management Scientist
1 week ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director to lead clinical trials for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases and/or Internal Medicine is desirable, and board certification in Pediatrics and/or Pediatric Infectious Diseases is highly desirable. At least 3 years of research and industry...
-
Cambridge, Massachusetts, United States Moderna Full timeDirector, Global Safety Physician, Rare Therapeutics page is loaded Director, Global Safety Physician, Rare Therapeutics Apply locations Cambridge, Massachusetts Clinical Development time type Full time posted on Posted 2 Days Ago job requisition id R15548 The RoleModerna employees currently can directly impact global health through the continued development...
-
Associate Medical Director US
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeAssociate Medical Director,US Medical Affairs, Rare Disease (2 positions) Full-timeRegion:USDepartment: Medical AffairsAbout this roleThe Associate Medical Director Rare Disease role is a part ofUS (United States) Medical Affairs, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve...
-
Associate Director, Clinical Pharmacology
3 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full timeCompany Description Bicycle Therapeutics (NASDAQ:BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high...
-
Director, Clinical Development
4 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a physician to develop, execute and lead clinical trials supporting one or more development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, Family Practice, Geriatrics, Pediatrics, or Obstetrics/Gynecology is desirable. At least two years of clinical research and/or industry...
-
Director, Global Safety Physician
1 month ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna employees currently can directly impact global health through the continued development of mRNA platform technology to address multiple important therapeutic areas with unmet medical needs. The Clinical Safety and Risk Management group supports Moderna mission to bring transformative mRNA therapies to patients and its commitment to patient...
-
Director, Clinical Development
2 days ago
Cambridge, Massachusetts, United States ModernaTX, Inc. Full timeThe Role:Moderna is seeking a physician to develop, execute and lead clinical trials supporting one or more development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, Family Practice, Geriatrics, Pediatrics, or Obstetrics/Gynecology is desirable. At least two years of clinical research and/or industry...
-
Senior Director, Clinical Development
2 weeks ago
Cambridge, Massachusetts, United States Moderna Theraputics Full timeThe Role:Moderna is seeking a physician to lead a clinical development program for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine and/or Geriatrics, or Obstetrics and Gynecology is desirable.This role will report to Moderna's Therapeutic Area Head, Clinical Development, Latent...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an experienced, versatile, pragmatic, and dynamic Executive Director Safety Physician Leader to help lead a Clinical Safety and Risk Management (CSRM) team of physicians in the Infectious Disease Therapeutic Area. The ideal candidate will be a seasoned safety professional with extensive medical expertise, drug disease insight,...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna employees currently can directly impact global health through the continued development of mRNA platform technology to address multiple important therapeutic areas with unmet medical needs. The Clinical Safety and Risk Management group supports Moderna mission to bring transformative mRNA therapies to patients and its commitment to patient...
-
Director of Facilities Operations and Events
3 weeks ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeDIRECTOR OF FACILITIES OPERATIONS AND EVENTS Athletics, Physical Education, and Recreation (DAPER)-Facilities, to collaborate with the director of athletics in providing strategic direction and oversight of the execution of designated day-to-day operations of athletic, physical education, and wellness, and recreational facilities. Responsibilities...
-
USA-Scientist III
1 month ago
Cambridge, Massachusetts, United States Randstad USA Full timejob summary: The primary purpose of the Clinical Scientist's position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to...
-
USA Scientist III Scientific
1 month ago
Cambridge, Massachusetts, United States Adecco Staffing, USA Full timeAdecco Medical & Science is seeking a remote contract Scientist for our Pharmaceutical partner based out of Cambridge, MA. The anticipated wage for this position is between $85 and $86.43. Hourly wage may depend upon experience, education, geographic location, and other factors.Benefit offerings include medical, dental, vision, life insurance, short-term...
