Manager/Associate Director, Medical Information and Drug Safety
Reporting to the Senior Director Medical and Scientific Communications, the Manager/Associate Director Medical Information and Drug Safety has responsibility for managing the outsourced call center which provides verbal and written responses to queries from healthcare professionals and collects the necessary information on adverse events and product complaints regarding OLINVYK. This role also provides primary oversight of the pharmacovigilance vendor providing post marketing adverse event tracking, follow up and reporting.
Specifically, the Manager/Associate Director, Medical Information and Drug Safety will be able to successfully accomplish the following responsibilities:
- Manage the externally-sourced Medical Information call center and act as point of contact to answer brand-specific questions and writing and reviewing answers given to external HCP customers as required,
- Writing standard response documents (SRDs) by searching, retrieving, evaluating and summarizing the relevant information from in-house and external data sources and literature,
- Update SRDs to maintain a current and accurate information resource for the call center,
- Provide ongoing product-related and SRD training for the call center staff,
- Monitor call center for quality and performance. Collect and analyze metrics for call center activities (including Medical Information, Pharmacovigilance, and Product Complaints) to assure timely and accurate responses or routing to appropriate internal departments for review and action; provide a report on a regular basis,
- Oversee and manage the call center and Pharmacovigilance vendor budgets, POs, and invoices,
- Develop and conduct regular assessments to ensure compliance with SOPs consistent with all legal, regulatory, and Company guidelines,
- Collect and analyze types of customer requests to provide input to brand strategy,
- Ensure timely delivery of peer-reviewed publications, AMCP Dossier or other relevant materials to HCPs upon request,
- Support medical information booth activities at key congresses,
- Provide training support for multiple internal customers (including but not limited to Sales team members, Health Economic/Medical Science Liaisons),
- Provide information support for commercial activities of the Brand Team (literature updates, literature searches; competitor information),
- Conduct medical data quality control (QC) reviews of promotional and non-promotional materials (as part of Medical-Legal Review) as requested,
- Manage Pharmacovigilance vendor to ensure appropriate follow up of adverse events and timely submission of pharmacoviglance reports to the Food and Drug Administration,
- Work with Pharmacovigilance vendor, consultant and/or Trevena physicians to complete causality and regular signal detection assessments,
- Manage Pharmacovigilance and Call Center vendors in response to drug safety and/or Medical Information audits,
- Observe compliance with all Trevena policies, SOPs and safety guidelines,
- Other duties as assigned.
EDUCATION & EXPERIENCE
- Registered pharmacist or Nurse (BSN); Advanced scientific degree (eg. Pharm D) preferred but not required
- Minimum of 2 years of experience in Medical Information within the pharmaceutical industry; Drug safety experience a plus
- Background/experience in opioid medications, IV analgesic medications preferred but not required.
- Experience working with Medical Information vendor preferred
KNOWLEDGE, SKILLS & ABILITIES
- Working knowledge of IRMS or other MI software,
- Must possess the ability to work across a matrix organization including: R&D, Regulatory, Legal, Commercial Operations, et cetera,
- Strong communication skills (verbal and written),
- Strong attention to detail,
- Strong personal integrity and customer focus are imperative,
- Thorough understanding of and compliance with the FDA, OIG, HIPAA, PhRMA and other regulatory/ethical guidelines relevant to the pharmaceutical industry.
Additional Preferred Skills
- Familiarity with pain management journals, and pain medical societies,
- Sound computer skills including Microsoft Word, and Powerpoint,
- Familiarity with PV software and reporting (eg. ARISg),
- Knowledge of the pharma marketplace and hospital selling environment,
- Familiarity with study design and statistical methodology,
- Experience working with medical, marketing and sales teams,
- Self-motivated and able to work in a fast-paced biotech environment.
Location: Trevena headquarters office in Chesterbrook, PA
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