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Manager, Clinical Pharmacovigilance and Medical Operations

3 months ago

Conshohocken, United States Madrigal Pharmaceuticals Corporation Full time
Job DescriptionJob DescriptionThis 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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