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Lead Manager, Postmarketing Safety Surveillance

2 months ago

Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Inc Full time

As a pivotal member of the team, the Lead Manager, Postmarketing Safety Surveillance will report directly to the Associate Director or higher within the Postmarketing Pharmacovigilance department. This role is essential in enhancing the safety evaluation, assessment, and risk management of products in the postmarketing phase, with a strong focus on safety monitoring activities.

Key Responsibilities:

  • Ensure that the postmarketing reporting procedures are streamlined and adhere to all regulatory requirements as outlined in the Safety Management Plan.
  • Collaborate effectively with the pharmacovigilance team on various tasks related to safety signals, data analysis, and safety data summaries. Aid in the collection of data for safety inquiries.
  • Contribute to the development of safety content for pertinent safety documents or sections.
  • Examine safety database listings for discrepancies and prepare draft queries as necessary.
  • Review relevant study documentation for safety-related insights for assigned projects, including registry protocols and Safety Management Plans.
  • Support the review of postmarketing data for Safety Review Team (SRT) evaluations.
  • Coordinate the scheduling of SRT meetings, including the gathering and distribution of meeting materials and agenda setting.
  • Assist in the preparation of aggregate report deliverables.
  • Help gather data to support labeling initiatives.
  • Oversee pharmacovigilance vendor activities, including assessment, evaluation, tracking, and reconciliation of safety information.
  • Manage the monthly reconciliation process conducted by the pharmacovigilance vendor.
  • Assist in the review of regulatory safety documents for assigned projects, such as Periodic Risk Benefit Evaluations, Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
  • Review Individual Case Safety Reports (ICSRs), including case narratives, causality assessments, and coding for assigned projects.
  • Engage with external partners and vendors regarding clinical pharmacovigilance tasks related to patient safety. Collaborate with the pharmacovigilance vendor to update relevant plans.
  • Support additional pharmacovigilance compliance activities as required. Maintain and create relevant departmental documents, such as expectedness lists and coding conventions.
  • Perform other duties as assigned.
Qualifications and Skills:
  • A Bachelor's degree in a relevant scientific field is required. Clinical experience (e.g., RN, BSN, or PharmD) is preferred but not mandatory.
  • A minimum of 6 to 8 years of direct experience in drug safety and pharmacovigilance, including case quality control and regulatory submissions of ICSRs globally.
  • Ability to interpret health and medical records, including adverse event reporting forms and discharge summaries.
  • Familiarity with safety databases; experience with Argus is advantageous but not essential.
  • Strong understanding of pharmacovigilance reporting regulations and timelines.
  • Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
  • Experience in clinical case processing, including MedDRA and WHO Drug coding and narrative writing.
  • Experience in managing external teams is preferred.
  • Exceptional attention to detail.
  • Excellent written and verbal communication skills.
Compensation:
The base salary is determined by various factors, including the successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also offer eligibility for bonuses, equity, and comprehensive benefits, including flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment decisions are based on qualifications, merit, and business needs. Applicants will be considered for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.

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 regarding employment would come from an authorized email address or from one of our trusted search firm partners. We are aware that incorrect or fraudulent email addresses, with Madrigal misspelled, have been utilized in these recent fraud attempts. If you receive unsolicited employment offers from individuals claiming to work for Madrigal, we recommend that you do not respond to their inquiries, do not open any attachments, and do not click on any hyperlinks.