Job Description
About the job Associate Director Drug Safety and Pharmacovigilance Operations
Job Title: Associate Director Drug Safety and Pharmacovigilance Operations
Job Location: Cambridge, MA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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 Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will be responsible for PV's role in expanded & early access programs (EAP) across the portfolio and other PV-related projects as assigned (e.g., Cross-reporting of SUSAR; Support Call Center for PV-related questions). The role will expand and evolve in line with Nuvalent's expansion as we approach potential market authorization.
Responsibilities - Oversight of EAP vendor, including, but not limited to, safety data exchange agreement maintenance and compliance monitoring
- Adverse event reconciliation between databases
- Oversight of safety reporting requirements for all EAP countries
- Primary point of contact for PV requests within the EAPs
- Support PV Operations team activities to ensure cross coverage across the portfolio
- Support regulatory inspections and serve as subject matter expert on PV's role in EAPs
- Identify potential risks and opportunities within the EAPs, keeping PV Leadership informed for proactive decision-making
Competencies Include - Excellent oral and written communication skills with high emotional intelligence
- Track record of effective decision-making and conflict management/resolution skills
- Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
- Detail and process orientated, with excellent project management, problem solving, and organization skills.
- Ability to think critically with strong attention to detail, effectively communicating verbally and in writing.
- Demonstrated project management and prioritization capabilities
Qualifications - Bachelor's degree in a relevant field or related experience.
- 8+ years of relevant experience within the biotechnology or pharmaceutical industry, including, 4+ years of experience in Pharmacovigilance operations
- Hands-on expert knowledge of Argus or equivalent PV database.
- 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.
- Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
- Expert knowledge of pharmacovigilance activities and processes, preferably in multiple PV functional areas
- Direct experience managing relationships with service providers or external business partners
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
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 "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a "" 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 857-357-7000. Thank you.
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