Associate Medical Director, Pharmacovigilance

<p><span style="font-family: helvetica, arial, sans-serif;"><strong>Company Overview</strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif;">Tango Therapeutics is a biotechnology <span class="markbkslheqjv" data-markjs="true" data-ogac="" data-ogab="" data-ogsc="" data-ogsb="">company</span> dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.</span></p> <p><span style="font-family: helvetica, arial, sans-serif;">Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.</span></p> <p><span style="font-family: helvetica, arial, sans-serif;">This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.</span></p> <p data-event-added="1"><span style="font-family: helvetica, arial, sans-serif;">The Tango labs and offices are located at <span class="HQEo7" data-markjs="true">201 Brookline Avenue, in</span> the Fenway area of Boston, Massachusetts.</span></p> <p><span style="font-family: helvetica, arial, sans-serif;"><strong>Summary</strong></span></p> <p style="text-align: justify;"><span style="font-family: helvetica, arial, sans-serif;">The Medical Director/Medical Reviewer, Pharmacovigilance will be responsible to perform medical review and assessment of Individual Case Safety Reports (ICSRs) and provide medical oversight. The Medical Reviewer will ensure clinical accuracy, consistency, quality, and compliance with applicable pharmacovigilance requirements.</span></p> <p><span style="font-family: helvetica, arial, sans-serif;"><strong>Your Role</strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif;"><em>Perform Medical Review activities </em></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review ICSRs from clinical trials, literature, solicited programs, and other sources</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Assess adverse events for seriousness, causality, expectedness/listedness, and clinical significance per regulations and company procedures</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Evaluate case details for medical consistency, including demographics, history, medications, labs, treatment, course, and outcomes</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review and validate MedDRA coding, diagnoses, events, indications, and relevant medical data</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Assess temporal relationships, de-challenge/rechallenge, alternative etiologies, risk factors, and outcomes, as applicable</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review, edit, and approve ICSR narratives for accuracy, completeness, concision, and clinical coherence</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Author robust and medically sound company comments for ICSRs, clearly documenting the company's medical assessment, clinical rationale, causality considerations, relevant medical history, alternative etiologies, and overall safety evaluation, as applicable</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review queries, identify key missing information, and recommend appropriate case follow-up queries</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Ensure proper documentation and escalation of significant safety information</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review vendor-created AOSEs/AOSE search terms for medical accuracy, completeness, consistency, and appropriateness</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Escalate medically significant cases and potential safety concerns to appropriate stakeholders</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Provide medical guidance to the vendor on findings and recurring quality issues</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Monitor quality and consistency, identifying trends that require training or process improvement</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Provide vendor guidance and feedback to maintain consistent ICSR quality</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Support activities related to creation or maintenance of PV procedures, medical review guidelines, AOSE criteria, training materials, quality metrics and other relevant activities</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Provide medical oversight of vendor-performed ICSR activities</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Review vendor deliverables for quality, accuracy, completeness, and timeliness</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Identify recurring medical review quality issues and share findings with the vendor</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Support vendor training and clarify medical review expectations, as needed</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Contribute to vendor performance monitoring and quality improvement</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Complete other ad hoc activities as assigned</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif;"><strong>What You Bring</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">4+ years of total relevant experience in Pharmacovigilance/Drug Safety, Clinical Research, or a related area. 2–5 years of hands-on ICSR medical review experience is preferred</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Relevant experience in Pharmacovigilance, Drug Safety, Clinical Research</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Hands-on experience in ICSR medical review and case assessment</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Experience reviewing AOSEs or other safety surveillance assessments is preferred</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Good understanding of ICH, GVP, FDA, EMA, and applicable pharmacovigilance requirements</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Working knowledge of WHO drug and MedDRA terminology and coding principles</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Strong clinical assessment, analytical, medical writing, and communication skills</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Ability to independently assess complex clinical cases and make sound medical judgments</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Excellent communication and cross-functional collaboration skills</span></li> </ul> <p style="text-align: center;"><span style="font-family: helvetica, arial, sans-serif;"><em>We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</em></span></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary range </div><div class="pay-range"><span>$194,400</span><span class="divider">&mdash;</span><span>$291,600 USD</span></div></div></div>