Job Summary:
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.
Job Responsibilities:
• 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 in 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 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
Competencies:
• 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.
Supervisory Responsibility:
None
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 to 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