Associate Director, Pharmacovigilance (PV) Operations, Somerville

Associate Director, Pharmacovigilance (PV) Operations

2 Days Old

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

Generate:Biomedicines is seeking an Associate Director of Pharmacovigilance Operations to support global case processing, safety reporting, and vendor oversight for late-stage clinical programs. Reporting to the Sr. Director, Pharmacovigilance, the Associate Director, Pharmacovigilance (PV) Operations will contribute to a full range of pharmacovigilance activities including but not limited to overseeing the management of individual case safety reports (ICSRs), supporting PV vendor oversight, contributing to inspection readiness, and help shaping internal processes that ensure robust and compliant safety operations. They will collaborate with key internal stakeholders including Clinical Operations, Biometrics, Data Management, Clinical Development, Regulatory Affairs.

Here's how you will contribute:

Ensure that Individual Case Safety Reports (ICSR) for assigned products are triaged, processed and submitted/distributed per global requirements and applicable SOPs
Perform ICSR assessments (seriousness, expectedness, causality) for clinical trial safety reports, including review of Analysis of Similar Events, where applicable.
Review ICSRs for completeness and accuracy; draft queries and ensure appropriate follow-up
Provide oversight of Drug Safety vendor(s) for all safety-related activities
Review key performance indicators in support of pharmacovigilance quality and vendor oversight
Represent PV/Safety on clinical study teams. collaborate cross-functionally to deliver on PV and study objectives.
Lead or contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
Lead, manage and contribute to preparation and review of periodic reports (e.g. DSUR).
Participate in SAE reconciliation, coding reviews and other study team activities
Participate in protocol development to ensure effective collection of safety data. Review and provide medical content and analysis, as needed, for regulatory documents and key study-related documents (e.g. ICF, SMC/IDMC Charters, clinical study reports).
Develop and deliver PV training materials including for Investigator Meetings or Site Initiation Visits
Support PV-related inspection and audit activities.
Lead or contribute to the development of PV processes and procedures to assure completeness and accuracy of safety data collection and ensure compliance with all relevant regulations.

The Ideal Candidate will have:

Bachelor's level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
Minimum of 5 years drug safety/pharmacovigilance experience in the biopharmaceutical industry, including at least 2 years of direct case processing (triage, data entry, QC, submissions) and 2 years of vendor oversight
Prior PV experience supporting global Phase 3 clinical trials
Line management or leadership experience a plus.
Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments.
Strong clinical judgement and ability to interpret and analyze safety data
Proficiency with validated safety databases (e.g., Argus, VeevaSafety) and coding dictionaries (MedDRA, WHODrug)
Excellent written and verbal communication skills, with ability to collaborate cross-functionally and across cultures.
Proficiency in Microsoft Office tools (Word, Excel, Outlook)
Highly organized, quality-minded, and able to manage multiple priorities in a dynamic environment.

Who Will Love This Job:

Individuals passionate about ensuring patient safety and operational excellence, and who see robust pharmacovigilance as essential to delivering transformative medicines.
Those who thrive in a dynamic, fast-paced environment, are comfortable with evolving responsibilities, and are energized by solving problems collaboratively.
Individuals who take pride in building and improving systems, love the details, and approach compliance and quality with curiosity and ownership.
Team players who value trust, accountability, and inclusive collaboration-balancing urgency with thoughtfulness and always working toward the greater good.

#LI-HM1

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Per Year Salary Range

$160,000-$224,000 USD

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Location:: Somerville

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