Veloxis Pharmaceuticals, Inc. Job Description

Job Title: , and Drug Safety Reports to: Chief Medical Officer Department: R&D and Medical Affairs Location: Cary, NC Date: October 2020 FLSA Status: Non-Exempt

POSITION OVERVIEW

The Vice President Pharmacovigilance & Drug Safety (VP, PV) will provide strategic and tactical leadership and be responsible for all aspects of Drug Safety, Pharmacovigilance and Risk through all stages of clinical development. This includes post-marketing , as required. This position reports to the Chief Medical Officer. The VP, PV will be responsible for setting and implementing the drug safety and Pharmacovigilance strategy for Veloxis, and for further developing the existing Pharmacovigilance and patient safety function within the organization.

The VP, PV will lead global clinical drug safety and Pharmacovigilance activities for products currently under development and preparing the Veloxis safety and Pharmacovigilance structure for the progression and commercial success of such products. This entails providing medical oversight for the global drug safety and Pharmacovigilance function to ensure proactive and timely benefit risk assessments of all safety data.

The Global Patient Safety function and its members are expected to serve as the safety experts to internal staff, interacting and collaborating across all relevant functions - Clinical Research, Clinical Operations, Regulatory Affairs, Quality, Medical Affairs and Commercial - providing strategic input on safety matters, including knowledge of product drug safety profiles.

The position plays a critical part in safeguarding the health of patients who are administered Veloxis’s products through the oversight of the collecting, evaluating, reporting and collating of adverse events, ensuring compliance with internal as well as external global regulatory and safety requirements. This position implements a scientifically valid early alert system to proactively discover trends and issues to provide Veloxis’s management with a global view of product safety.

The scope of this position includes oversight of all Pharmacovigilance and clinical drug safety related to: (1) quality systems; (2) safety assessments and surveillance; (3) secondary data analysis capability; (4) compliance; (5) regulatory authority reporting; (6) benefit-risk assessments; (7) risk identification and mitigation management; (8) vendor management and oversight; and (9) communication of safety information.

SUMMARY OF KEY RESPONSIBILITIES

• Provides strategic oversight and direction of all aspects of Pharmacovigilance and risk management activities for investigational compounds (and eventually marketed products); • Provides strategic oversight and implementation of the design, direction and conduct of ongoing safety surveillance of the Company’s drug products to ensure delivery of high quality Pharmacovigilance services; • Provides strategic planning, implementation, and management of drug safety activities to support clinical development of the Company’s products; • Conducts the assessment and adoption of the most up-to-date Pharmacovigilance approaches to drug safety, including, but not limited to, consideration of the latest (secondary) data collection and analysis techniques; • Leads the strategy for review and revision of relevant SOPs to conform to new standards and/or organizational needs, building on existing Drug Safety and Pharmacovigilance functions; • Oversees and contributes to the daily operations of the Pharmacovigilance department, including oversight of the activities of contract research/service organizations (CROs/CSOs) and individuals contracted to perform drug-safety and Pharmacovigilance activities; • Designs and implements a safety governance structure (safety management teams, global benefit-risk board, etc.), providing leadership, as appropriate; • Takes a leadership role in responding to and resolving safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans; • Ensures proper negotiation of contracts and interaction and supervision of all the activities related to CROs / CSOs and consultants for drug safety and Pharmacovigilance services; Page 2 of 5

• Provides ongoing updates to the Company’s senior executive management on the changing risk/benefit profile of the Company’s drug products in clinical trials based on analyses/evaluation of potential safety signals, and implements appropriate safety updates and risk mitigation plans; • Ensures oversight of patient safety in all clinical trials; • Provides for the oversight for all clinical safety activities including review of medical coding of adverse events, concomitant-medications, and processing of serious adverse events through the entire lifecycle, including preparation of Analyses of Similar Events for Suspected Unexpected Serious Adverse Reactions from clinical trials; • Oversees and ensures Global Patient Safety team capability to develop, prepare and comply with periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc.), investigator communications and other reports, as necessary; • Leads the responsible team while also participating directly in the preparation and review of safety sections of all critical documents for development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical study reports, INDs, CTAs, NDA/BLA/CTD); • Contributes to and provides medical Pharmacovigilance review of the Company’s Core Data Sheets, patient information leaflets and summary of product characteristics; • Contributes to the development of processes regarding signal detection and evaluation; • Ensures that the Company’s Pharmacovigilance tools (i.e., databases such as ARGUS, etc.) are kept to appropriate standards and upgraded regularly, as required; • Ensures compliance with applicable regulatory requirements related to Pharmacovigilance and Risk Management Plans for Veloxis’s products.

REQUIRED QUALIFICATIONS AND SKILLS

• Medical Degree (MD or DO), required. • 10 years’ Pharmacovigilance experience; 15 years’ total industry experience. • Expert level knowledge of global regulatory and legal requirements related to Pharmacovigilance. Working knowledge of industry-standard Pharmacovigilance databases and related tools and risk management processes/practices. • Demonstrated ability to lead effectively. • Must possess the ability to quickly develop rapport and credibility, both inside and outside of the organization; • Outstanding interpersonal, management and team organizational skills; • Ability to successfully drive results through positive teamwork within the Pharmacovigilance team and across departments, exhibiting and inspiring integrity, credibility, confidence and urgency.

Other Skills and Specifications:

• Highly developed analytical reasoning, attention to detail and applied learning skills. Must possess self- initiative with the ability to make independent decisions and the judgment to know when to seek guidance. • Proven ability to work independently and autonomously, as well as within a team. • Demonstrated ability to professionally manage time, prioritize multiple responsibilities, and conduct work in a timely and accurate manner with a high level of attention to detail. • Excellent collaboration skills. • Effective process and project management skills. • Solution-oriented. • Outstanding written and verbal communication skills. • Expert knowledge of scientific principles and concepts.

Page 3 of 5

Supervisory Responsibility: Direct Reports Yes No Indirect Reports: Yes No

Confidential Data: Yes No Budgetary Responsibility: Yes No Travel Requirements: 30%

All position requirements listed indicate the minimum level of knowledge, skills and/or experience necessary to perform the job proficiently. This job description is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Employees will be required to perform any other job-related duties as requested by their supervisor, subject to reasonable accommodation.

Page 4 of 5

Physical Demand Analysis

Work Environment: Climate-controlled office Works remotely from home office, traveling to worksites, as assigned Physical Demands Associated with this Position: The physical demands are minimal.

Physical Demands of Essential Functions: O = Occasional F = Frequent C = Constant

Weight Involved (if applicable) Activity Frequency of Action Under 20 lbs 20-60 lbs Over 60 lbs O F C O F C O F C O F C Standing X Walking X Sitting X Carrying X X Bending X Lifting X X Pushing X X Pulling X X Twisting X Reaching X Seeing X Gripping X Hearing X Occasional = 1%-33% of time Scale Frequent = 34%-66% of time Constant = 67%-100% of time

Page 5 of 5