A program-level role within the Pharmacovigilance Department, this role will provide oversight for planning and development projects and activities within the Corrona PV team. The role will collaborate with internal and external stakeholders to support prioritized planning and development projects and deliverables including protocols, questionnaires, reporting plans and templates. As lead on a variety of priority departmental initiatives, this position requires comprehensive understanding of end-to-end processes from data collection to analysis and will provide oversight and mentoring support for junior team members on planning activities.
The Program Manager – PV Planning and Development will play a role in the following functional capacities:
• Demonstrate thorough understanding of Corrona’s observational research model as relates to data collection, safety surveillance and reporting activities for AEs of special interest, in accordance with internal SOPs, work instructions and subscriber reporting plans
• Demonstrate familiarity with relevant regulatory guidance documents and governing legislation applicable to Corrona’s PV service model and incorporate into operations and documentation
• Lead a number of internal and/or external workgroups and conference calls, demonstrating appropriate oversight, documentation and follow-up with minimal supervision.
• Act as a PV planning lead and/or in an oversight capacity for work with subscriber safety leads/project teams, departmental and cross-functional stakeholders to collect and refine inputs for a range of planning and reporting deliverables (e.g. report plan development, safety questionnaire updates, report templates)
• Facilitate planning discussions with internal and external stakeholders as appropriate to support decision making existing and proposed projects; clearly and accurately document and communicate decisions.
• Demonstrate initiative to deliver on committed (internal and external) safety reporting and/or planning deliverables; provide updates at appropriate intervals to facilitate alignment and forward-progress.
• Familiarity with contractual obligations, deliverable requirements and organizational requirements applicable to PV operations
• Other duties as assigned (temporary or permanent, based on company needs)
EDUCATION & EXPERIENCE
• Advanced degree in research (e.g. epidemiology, public health, pharmacy, research)
• 5 + years of relevant experience (drug safety, research design, clinical research, risk management, program management or equivalent).
• Strong written and verbal communication skills – must be proactive and highly responsive
• Flexibility to adapt to shifting team and organizational priorities
• Must be highly organized and detail-oriented, with excellent time management skills
• Able to work independently and as a part of a team
• Strong proficiency in the entire Microsoft Office Suite
• Additional duties may be assigned, either temporary or permanent based on company needs
• Completion of Human Subjects Protection (HSP) training (provided by Corrona)
• Boston area or Remote position
• Must be able to remain in a stationary position 50%
• Travel within the US - up to 15%