ACDL is looking for a director safety sciences for one of its clients,

SUMMARY OF KEY RESPONSIBILITIES
• Manages all Company pre- and post-marketing safety surveillance activities for its assigned products (investigational and marketed) throughout the life cycle in compliance with ICH guidelines, FDA/EMA applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Company procedures.
• Leads and provides input to the Company’s Global Safety Strategy ensuring continuous review and assessment of pre-clinical, clinical, and post-marketed safety data to ensure positive benefit risk profile for assigned programs in collaboration with stakeholders.
• Provides Pharmacovigilance and Drug Safety leadership and input for the Company’s clinical development programs, including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs. Collaborates with Clinical Science, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), and other internal and external entitles to contribution to the overall study execution while ensuring Safety strategy, Quality compliance and operational excellence.
• Participates in the Safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA) at type C, B, pre-BLA/MAA/NDS meetings, Advisory Committees meetings, or other scientific advice forums.
• Provides medical review of individual Case Safety Reports (clinical and spontaneous) and all Safety analyses to ensure accurate coding (MedDRA and WHO Drug), seriousness, expectedness, and Company causality assessment, appropriate medical interpretation, consistency in case assessment, and accurate reporting to health authorities, committees, and collaborators.
• Leads and contributes to the preparation and review of medical/scientific assessments of Safety data, including Safety-related section(s) for clinical, regulatory, and scientific documents, including protocols, informed consent/assent forms, Case Report Forms (CRFs), statistical analysis plans, clinical study reports/synopses, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory agency responses, IRB/EC requests, briefing books, manuscripts/journal article, and other documents, ensuring safety profile is reflected for assigned products.
• Directs the creation and maintenance of the Company’s Core Safety Information (CCSI) and ensures implementation of CCSI in all Reference Safety Information (RSI), including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels, and other associated product labeling.
• Leads signal detection activities to ensure signal identification, evaluation, and validation for assigned products, including single and aggregate data analyses, interpretation of safety signals and trends, documentation, and communication of safety assessments (written and verbal) of safety risks in collaboration with essential team members.
• Prepares and participates in Safety Management Team (SMT), Benefit Risk Assessment Team (BRAT), and other forums for assigned products.
• Leads and contributes to the preparation of pre- and post-marketing aggregate Safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and Six-Month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports. Ensures safety profile/topics across various Regulatory Safety documents for the Company’s assigned products.
• Leads risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization, and effectiveness measures in accordance with Regulatory requirements.
• Involved in inspection readiness activities, internal audits, and external inspections.
• Maintains knowledge of disease states for assigned investigational and marketed products.
• Maintains informed of new PV/Safety regulations and guidance from Regulatory authorities.

REQUIRED QUALIFICATIONS AND SKILLS
• Advanced degree in healthcare field required, such as MD, PharmD, PhD, RN, or BSN.
• Minimum 7 years’ experience in pharma/biotech industry, with 4+ years in Pharmacovigilance/Drug Safety.
• Superior medical writing skills, especially on Safety Signal, ISS, RMP, DSUR, PSUR, PBRER, etc.
• Successful experience in BLA/MAA with various Regulatory authorities (FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums preferred.
• Solid experience in the principles and techniques of data analysis with proficiency in data analysis software and data presentation, interpretation, and clinical relevance.
• Solid experience in developing successful Risk Mitigation, Implementation and Assessment strategies.
• Expertise in generating Safety data presentations for various Safety meetings.
• Expertise in medical assessment of an ICSR, including Company assessment of causality, both independently and in collaboration with guidance provided by department standards.

If you think this is you Apply now!