- Horsham, PA
What you'll be doing
- Strategically plan and ensure timely, quality reports or safety analyses related to core deliverables. Lead collaboration with therapeutic area safety head and other stakeholders on strategy development for individual reports. Lead collaboration with TASH or MSO or PVP and other stakeholders on strategy development for assigned products across report types in alignment with development milestones. Oversee search execution. Independently perform or lead aggregate safety analysis and case level review. Independently author, contribute and coordinate the preparation of core safety deliverables. Assigned complex products and reports where coordination and leadership of multiple scientists is required. Ensure commitments (e.g., PVAs, assessment reports) are met. Partner with vendor to develop reports or deliverables. Work closely with management to proactively support TA-related business. Serve as therapeutic area lead back up. Provide enhanced safety management team (SMT) support to enable proactive safety management. Act as core member for assigned products. Be responsible for product accountability by maintaining product intelligence (i.e., creating agendas and documenting decisions, milestones, action items in minutes). Deliver innovative solutions for aggregate safety strategy and analyses. Provide enhanced safety management team (SMT) support to enable proactive safety management. Participate in cross-functional training of relevant stakeholders. Act as product or process subject matter expert (SME) or departmental representative, during audits or inspections. Identify training needs and develop or execute training plan for department and departmental or cross-functional initiatives. Lead department or cross-functional initiatives. Work closely with team members to ensure a consistent approach to deliverables in the assigned TA and across department.
What your background should be
- A minimum of 3 years of experience in clinical or medical writing or pharmacovigilance is required. Project management experience required. Experience leading matrix medical or scientific project teams or sub-teams is preferred. Excellent English verbal and written communication skills are required.
Required Schooling / Training
- A minimum of a bachelor degree in health or biomedical science or equivalent.
Who is the client company
- This is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer.
- If you are interested in this position, send your resume to firstname.lastname@example.org