Senior Director Drug Safety and Pharmacovigilance

Found in: Jooble US O C2 - 2 weeks ago

San Diego CA, United States ACADIA Pharmaceuticals Inc. Full time

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. Responsible for content and quality of Acadia risk communications.
Develop strategies, working with the Head of Safety, to achieve PV Medical Safety goals.
Assess safety signals and trends and proactively manage any potential safety issues.
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.
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. Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
Strength in analysis, critical decision-making and bottom line accountability.
Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
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.
Proficient computer skills, including Argus, Microsoft Word, PowerPoint and Excel.
stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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