Responsible for defining overall strategy and approaches within Medical Safety, including leading a Safety Management Team, supporting the VP of PV 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 SVP of PV, to achieve PV Medical Safety goals.
- Along with the Corporate Safety Officer, represent PV in communications with health authorities such as the FDA.
- Oversee and approve contributions of Medical Safety team with respect to study protocols, Investigator Brochures, and other safety-related documents / communications.
- Ensure the ongoing performance of signal management activities.
- Assess safety signals and trends and proactively manage any potential safety issues.
- Lead the Safety Management Team and communicate, as appropriate, to ACADIA management.
- Formulate response strategies for health authority requests.
- Determine need for pharmacoepidemoiology input and liaise with external pharmacoepidemiologist.
- Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and ACADIA standards.
- Perform medical review of ICSRs for assigned product(s).
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (PADER, PBRER/PSUR) and ad hoc safety assessments.
- Provide oversight for the safety aspects for 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 for department staff.
- Other duties as assigned.
- MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
- MPH or pharmacoepidemiology expertise a plus.
- A minimum of 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 8 years of safety leadership experience.
- Neurology, psychiatry, or CNS-related disease experience a plus.
- 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 among team members and effectively aligning resources 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 Harmonisation (ICH) guidelines.
- Extensive knowledge of all types of aggregate safety reports.
- 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 Microsoft Word, PowerPoint and Excel.
Establishes strategic plans for designated function(s) and participates with others in management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company.
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. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity