- Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
- Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
- Participate in the daily management, operational oversight and execution of operational safety tasks for all Nuvalent clinical programs.
- Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up and timely submission of expedited safety reports.
- Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
- Ensure safety case queries are resolved as per defined processes (interfacing with clinical operations team and clinical vendors, as required) and facilitate case closure within required timelines.
- Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
- Serve as PV operations SME on safety reporting processes according to study protocol.
- Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
- Ensure procedural deviations are appropriately documented and corrective action plans arising from audits and inspections are put in place.
- Responsible for the operational aspects of safety inspection readiness activities in collaboration with department leadership.
- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
- Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
- Obtain/provided regularly scheduled listings of AEs/SAEs for safety reviews.
- Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation process.
- Responsible for the development of safety management plans, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered too.
- Excellent written and verbal communication skills.
- Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
- Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
- Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
- Demonstrated project management and prioritization capabilities.
- Bachelor's Degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
- 7 + years of progressive drug safety experience in a biotech/pharma, Medical Device or a CRO company.
- Clinical Development experience.
- Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
- Ability to interpret and follow regulatory guidelines.
- Proven knowledge of Good Documentation Practices and cGXPs.
- Basic knowledge of MedDRA coding.
- Experience in ICSR case-processing and reporting.
- Experience working in and with safety databases.
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Nuvalent, Inc. Cambridge, United States**The Company**: · With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans ...
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director, pharmacovigilance operations
3 weeks ago
BioSpace Cambridge, MA, United StatesJob Details · 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, Pharmacovigila ...
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Director, Pharmacovigilance Operations
3 weeks ago
Sana Biotechnology Cambridge, United States Full timeAbout 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 ...
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Nuvalent, Inc. Cambridge, United StatesAssociate Director, Pharmacovigilance Operations · The Company: · With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing togeth ...
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Pharmacovigilance Operations Lead
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Tetraphase Pharmaceuticals Waltham, United StatesPosition Title · Pharmacovigilance Operations Lead (contractor) · Department · Pharmacovigilance · Reports to · Head of Pharmacovigilance · Location · Hybrid · Details · Exempt · Direct Reports · none · Company Overview: · Innoviva Specialty Therapeutics is dedicated to bringing ...
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Vice President, Head of Safety
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Astria Therapeutics Inc Cambridge, United States**Position Overview**: · Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be res ...
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Director, Gcp
5 days ago
Astria Therapeutics Inc Cambridge, United States**Position Overview**: · Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria's pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kall ...
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Manager, Safety Statistical Programming
1 week ago
AbbVie Boston, United States**Company Description** · The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in th ...
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Associate Director Research
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Sarepta Therapeutics Cambridge, United StatesThe Associate Director, R&CD Quality Assurance will be responsible for the delivery and execution of the Sarepta internal and external audit program, risk based audit plan development, and the conduct of GLP/GCP/GVP audits. The Associate Director will participate in vendor risk a ...
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Manager, Statistical Programming
1 week ago
Moderna Cambridge, United States**The Role**: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliv ...
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ONO PHARMA USA Cambridge, United StatesThis is a Senior Manager level role that oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to organization's clinical development programs. · Develops and designs pharmacovigilance processes and procedures to ensure complianc ...
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BioSpace Cambridge, United StatesJob Details · Why 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 a ...
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Associate Medical Director
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Akebia Therapeutics, Inc. Cambridge, United StatesNearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. · At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that s ...
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Intellia Therapeutics Cambridge, United StatesWhy 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 strong ...
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Vice President, Pharmacovigilance
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Nuvalent Inc. Cambridge, United StatesThe Company: · With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with ...
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Director, Inspection Management Lead
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Pfizer Groton, United StatesROLE SUMMARY · The Director, Inspection Management Lead supports Pfizer as required by preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor as appropriate) co ...
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Sr. Drug Safety Specialist, Compliance
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Proclinical Cambridge, United States ContractSenior Drug Safety Specialist, Compliance - Contract - Cambridge, MAProclinical is on the lookout for a dedicated and experienced professional to fill the role of Drug Safety and Pharmacovigilance Compliance Specialist. This is a contract position located in Cambridge, MA. · Prim ...
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Associate Medical Director, Drug Safety
2 weeks ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, i ...
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Associate Medical Director, Drug Safety
1 week ago
Biogen Cambridge, United StatesCompany Description · Job Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials ...
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Clinical Scientist
2 weeks ago
The Fountain Group LLC Cambridge, United StatesThe Fountain Group are a national staffing firm and are currently seeking a Clinical Scientist for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: · Job Description:Pay: /hr. · 12 month assignment to start with potentia ...
Associate Director, Pharmacovigilance Operations - Cambridge, United States - Nuvalent, Inc.
Description
The Company:With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.The Role:
Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Director, Pharmacovigilance will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will serve as the primary point of contact and liaison for the CRO which performs case processing activities for Nuvalent. They will work in close collaboration with pharmacovigilance physicians on operational safety issues and cross-functional team members. This individual will ensure that case processing vendors are following the safety management plan and providing high quality ICSRs, through close oversight and collection and analysis of KPIs.
Responsibilities:
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a "no-" email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at Thank you.
Associate Director, Pharmacovigilance Operations professionals in Cambridge
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Brian Sodano
Build Engineering Teams, Products, and Platforms.