- Develop strategies, working with the Head of Safety, to achieve PV Medical Safety goals.
- Along with the Head of Safety, represent PV in communications with health authorities such as the FDA.
- Assess safety signals and trends and proactively manage any potential safety issues.
- Formulate response strategies and author responses for health authority requests.
- Determine the need for pharmacoepidemiology, including input and liaise with external pharmacoepidemiologists.
- Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Acadia standards.
- Assist with oversight of the vendor performing medical review of ICSRs and aggregate report on behalf of Acadia.
- Perform medical review of serious adverse events from Acadia clinical trials.
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, and ad hoc safety assessments.
- Provide oversight for the safety aspects of clinical studies, and development and maintenance of the company core safety information.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed.
- Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
- Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
- Author analysis of similar events (AOSE) and individual case comments for ICSRs.
- Maintain knowledge of global regulatory authority regulations including FDA and EMA.
- Contribute to the training, leadership and continuing education of department staff.
- Other duties as assigned.
- Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
- Proficiency at creating and communicating a clear vision and activities to achieve functional area and/or organizational goals.
- Strength in analysis, critical decision-making and bottom line accountability.
- Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
- Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
- Extensive experience in authoring of all types of aggregate safety reports including setting a strategy to address potential safety issues.
- In-depth understanding of the drug development process.
- Extensive experience in partnering with vendors to achieve results.
- Exceptional written and verbal communication skills.
- Skilled at negotiating with business partners or managing and influencing senior level leaders regarding matters of significance to the organization.
- Ability to think strategically at the executive level, implement change, incorporate innovation, and implement strategies throughout all levels of the organization.
- Ability to build and sustain trusted relationships both internally and externally.
- Proficient computer skills, including Argus, Microsoft Word, PowerPoint and Excel.
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Senior Director Drug Safety and Pharmacovigilance - Princeton, United States - ACADIA Pharmaceuticals Inc.
Description
Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.
Responsible for supporting the overall strategy and approaches within Medical Safety and supporting the PV management on scientific topics, and interacting with Acadia executives/leaders with respect to issues related to benefit/risk.
Primary Responsibilities
MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification. Targeting 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience. MPH or pharmacoepidemiology expertise desired. Neurology, psychiatry, or CNS-related disease experience preferred.
Key Skills:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations.
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