Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem Biosciences aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company's first commercial product, Phexxi™ (lactic acid, citric acid and potassium bitartrate), is approved in the United States for the prevention of pregnancy. The Company is advancing EVO100 for the prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women.
We are a growing team based in San Diego, CA. Our sole purpose is also our soul purpose: to improve the lives of women. We are committed to discovering and developing innovative healthcare solutions that put women first.
The Associate Director/Director, Pharmacovigilance will lead the evaluation of post-marketing adverse events, medical review of post-marketing adverse event reports, combined medical device reports, and assist with aggregate reports and signal detection activities across the clinical development programs and post marketed programs. The Associate Director/Director leads the day-to-day operational activities of the Pharmacovigilance functions, interacts with the PV and social media vendors, and ensures that performed tasks comply with Evofem’s SOPs and policies, best industry standards, and applicable regulations. S/he will interface with various functional areas and external resources, collaborating with regulatory, quality, contract research organizations (CROs), medical affairs, commercial, and drug development colleagues to ensure that product safety pharmacovigilance is performed adequately across all ongoing clinical trials and in support of marketed products.
· Oversee product safety surveillance and evolving safety profiles for clinical and marketed products
· Review and approve drug safety information in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA
· Perform case review, including causality assessments of AEs/ADRs for both marketed and pre-marketed products and medical device reports, interfacing with reporters as needed.
· Perform scientific review and evaluation of individual and aggregate adverse events reports, line listings for PBRERs/ IND annual reports and assesses them in accordance with appropriate regulations/guidelines and internal procedures.
· Identify and analyze safety signals emerging from individual or aggregate safety event analyses: performing aggregate analyses of specific events across studies, as indicated
· Track safety (individual and aggregate) and case data including (but not limited to) to the following activities:
o Aggregate safety data captured in the safety database (including SAE, pregnancy, overdose).
o Reconciliation with the clinical data captured in the clinical database.
o Product quality complaint (PQC) and Adverse Event (AE) and reconciliation with PV vendor safety database for combined AE/PQC reports.
o Reconciliation with social media vendor AE/PC logs
· Oversee investigational and/or approved drug safety updates, investigational new drug safety reports, investigator communications, contributes to the development of Aggregate reports including Periodic Benefit-Risk Evaluation Reports (PBRERs), risk management plans and other reports as necessary.
· Lead the periodic comprehensive cross-functional internal safety and risk management meetings with responsibility for identification and interpretation of any new safety signals on an ongoing basis.
· Participate on cross-functional product/project teams including review of protocols, clinical study reports, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
· Lead the implementation of Pharmacovigilance training programs for both internal and external use
· Liaise with Medical Affairs, Commercial, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders
· Interface with PV vendor(s), social media vendor and medical information call center vendor and serve as the PV contact person for these vendors.
· Conduct quality control processes of the post marketing and pre-marketed ARGUS cases as part of vendor oversight.
· Track key performance metrics of the PV vendors
· Develop and maintaining of the PV contracts, safety data exchange agreements
· Contribute to PV section of study reports and aggregate reports by reviewing the AE/SAE case listings.
· Support regulatory inspections and audits of PV vendors and contract research organizations that perform PV-related activities.
· Archive PV and related documents accurately and in a timely manner
· Maintain general PV correspondence and timelines for PV projects
· Monitor industry best practices and global safety regulations to ensure continuous compliance
· Must have excellent accountability, facilitation, organizational, analytical and time management skills.
· Must be detailed oriented, possess excellent time management skills, be well organized, and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
· Must be able to work as a team member, multi-task, and maintain day-to-day activities while being responsive to changing priorities.
· Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others in a positive and collaborative manner; able to communicate with sense of urgency to internal and external customers.
Education and Qualifications:
· M.D, PharmD or Nursing degree (R.N or N.P) required or internationally recognized equivalent with minimum 2-year clinical experience with patients following graduate training preferred
· Minimum 5 years of Pharmacovigilance and/or Biopharmaceuticals industry.
· Experience in women’s healthcare preferred.
· Good working knowledge of drug safety databases (preferably ARGUS) and MedDRA.
· Knowledge of FDA and EU, ICH adverse event reporting regulations and the ability apply applicable regulations to maintain compliance.
· Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
· Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
· Knowledge of principles of epidemiology and statistics.
· Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.
Travel: Ability to travel 10-20% domestic.
Evofem Biosciences provides a competitive salary and generous benefits package including medical, dental, vision coverage, 401k, paid vacation and Holidays.
Evofem Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, military or veteran status, disability, or any other basis protected by applicable law.
If you need a reasonable accommodation to complete the application process, due to a disability, please contact Human Resources at email@example.com.