Chimerix

Safety/Post Marketing Project Manager

The Safety Post Marketing Project Manager will provide leadership and project management capabilities for the Safety/Post Marketing team.  This position will liaise with internal management teams, functional leaders and external partners championing a culture of delivery, transparency, and clear communication.

Responsibilities:

• Serve as point of contact for Safety/Pharmacovigilance Vendors & Partner companies for all pharmacovigilance related activities.
• Develop/oversee execution of PV processes and deliverables performed internally, or contracted to vendors/independent consultants to ensure compliance/alignment with regulatory requirements and internal policies/procedures.
• Oversee the development, review, and maintenance of Standard Operating Procedures, working procedures, guidance documents governing Pharmacovigilance functions, as applicable, to ensure appropriate build out of procedures/processes to keep abreast of the company’s growth/evolution.
• Oversee and manage SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings.
• Participate in launch preparedness activities to achieve timely implementation of new processes/procedures to ensure compliance with regulatory requirements.
• Oversee and monitor Key Process Indicators (KPIs) to assess the effectiveness of pharmacovigilance processes.
• Contribute to maintaining case quality/compliance including the relevant budget management.
• Partner with members from the Quality Department to align compliance processes and procedures with existing or required quality processes.
• Contribute to the development and implementation of pharmacovigilance activities within the Quality Management System.
• Collaborate with cross-functional teams, including medical affairs and manufacturing to assess and manage risks related to pharmacovigilance activities.
• Lead departmental and cross-functional meetings, as needed, and initiatives to increase the awareness, education, training, and leadership for pharmacovigilance compliance.
• Manages the audit process of business partners, CROs, and vendors and adherence to contractual agreements in regard to compliance with pharmacovigilance activities.
• Collaborate with internal audit teams and external partners during regulatory inspections and audits
• Track all relevant corrective action / preventative action details from inspections and audits to completion.
• Serve as a primary liaison with Quality Affairs during an FDA Postmarketing Adverse Drug Experience & REMs inspections to ensure that questions and matters are adequately addressed.
• Serve as a Safety/PV point of contact for interactions with business partners, and a Subject Matter Expert in internal and external pharmacovigilance audits performed by business partners to ensure that questions and matters are adequately addressed.
• Collaborating with applicable team members including individuals focused on the clinical aspects of drug safety to manage the Drug Safety budget & work closely with finance to track and adjust budget forecasts and spends.
• Inform leadership/senior management of any concerns/issues requiring higher-level notification/input and providing regular updates to internal department regarding pharmacovigilance related activities affecting their function.
• Other pharmacovigilance related functions assigned.
• Review documents (Safety Management Plan, RRRT, Joint Operating Guideline etc.) related to vendor and Chimerix activities
• In collaboration with biostatistics, safety, clinical and data management drive the process for requisition, review and QC of data outputs generated for routine/periodic analysis
• Monitor label version updates liaising with regulatory affairs for Chimerix compounds and comparator therapies

Preferred Qualifications:

• A minimum of a bachelor’s degree in a health/biomedical or related field, OR Registered Nurse, Licensed Practical Nurse, or Pharmacist with current certification/licensure (e.g., LPN, RN, RPh, PharmD) required.
• Minimum of 5-7 years of experience in a drug safety/pharmacovigilance setting, including understanding the relationship to other functional outputs.
• Must have good working knowledge of FDA, EU, ICH, and other global regulatory requirements.
• Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
• Must have experience in vendor oversight, budget management, and the management of safety data exchange agreements.
• Ability to lead contractual and budget negotiations with vendors.
• Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting.
• Knowledge of and experience in REMS program operations and implementation.
• Knowledge of and experience with case processing and periodic report preparation (Drug Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER)/Periodic Benefit-Risk Evaluation Report (PBRER)).
• Current knowledge of and experience with MedDRA.
• Regulatory experience a plus.