This position will play a key role in supporting the safety assessment, evaluation and risk management of products in various stages of development as well as involvement in safety surveillance activities.
This position reports into the VP, Pharmacovigilance & Medical Operations
Position Responsibilities:
Review ICSRs (including case narratives, causality assessments and coding) for assigned projects
Assist with oversite of clinical pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information. Oversee monthly reconciliation process performed by PV vendor
Review eCRF data listings, as assigned, for inconsistencies and provide draft queries to appropriate team members
Assist with data collection for development of safety content for relevant safety documents
Review relevant study documents for safety-related information for assigned projects (e.g. Protocols, Safety Management Plan, SAE Reconciliation Plan, CRF, etc.)
Support aggregate report deliverables, such as writing and review of regulatory safety documents for assigned projects, e.g., Development Safety Update Reports (DSURs), Mexico annual report
Interface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasks
Assist with Adjudication Committee activities including case identification, tracking, collection of appropriate data/records for submission to adjudication database
Assist with Data Monitoring Committee activities, as needed
Assist with other PV compliance activities as required
Other duties as assigned
Qualifications and Skills:
Bachelor’s degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred, but not required
Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide
Ability to interpret health and medical records such as adverse event reporting forms, discharge summary, etc
Experience with safety databases; Argus is a plus but not mandatory
Experience with EDC for clinical trial data collection
Experience with clinical case processing, including MedDRA and WHO Drug coding and narrative writing
Good knowledge of pharmacovigilance reporting rules and timelines
Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
Experience in managing external teams preferred
Excellent written and verbal communication skills
Excellent in detailed-oriented tasks
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Health Care Provider
Industries
Internet Publishing
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