Medical Director;Drug Safety-CNS

Job Summary To ensure medical input into the safety profile of allocated AZ products (particularly for the Neuroscience therapy area) including medical input into compliance, labeling and clinical studies. Ensures key internal and external communication or medical safety assurance related to assigned products.

Major Responsibilities
Accountabilities:
? Narrative review for medical content
? Identifying and evaluating signals in safety surveillance
? Interpretation of data and determining significance of safety surveillance
? Communicate findings/conclusions and implications of reports
? Communicate safety surveillance information to internal and external stakeholders according to procedure
? Identifying labeling issues and providing safety expertise to labeling process

Responsibilities:
? Identify and utilize external contacts in academia and industry medical
? Providing product safety knowledge
? Providing key internal interfaces with marketing/sales (safety content)
? Providing key internal interfaces with CDMA especially clinical medicine and Drug Regulatory Affairs
? Assessment-medical review (PSUR?s, Safety Statements, Safety Surveillance Plans, Discussion Documents and Justification Documents for SERM)
? Review of coding (mapping to standards)
? Review of medical content
? Active participation on appropriate team, risk management, formulating action plan/implementation, information gathering/extracting data, monitoring results of action plan, and provide safety data expertise
? For labeling, monitoring results/follow through
? Safety expertise to clinical - input/contribution/participation in clinical strategies development teams, representation on study working teams, input to investigator meetings, input to clinical regulatory submissions, leading role in safety reviews and safety issue management, input into IND annual updates
? Conduct thorough product safety evaluation during in-licensing/acquisition projects (being part of a cross-functional team)
? Assistance with clinical database SAE reconciliation where arbitration is necessary
? Link with DSMBs and external safety committee
? Input into clinical trials, CSRs and ISSs
Internal and External Contacts/Customers
? IT
? Legal
? QA Auditors
? Consultants
? HR
? Global Safety
? Marketing/sales
? Clinical Development and Medical Affairs
? Regulatory Affairs

Reporting Relationship
? Direct Reports ? 0
? Indirect Reports ? 0


Responsibilities

Minimum Requirements
Education:
? MD/DO or equivalent degree from reputable international medical university
Board certified/eligible in primary care specialty preferred
Experience:
? 3 years clinical research background/and or 2-3 years pharmaceutical industry experience
? 3 years clinical practice experience
? Working knowledge of epidemiology

Preferred Background
? 1 year of safety experience in a pharmaceutical industry
? Board certified/eligible in primary care, specialty or related specialty in Neuroscience,internal medicine or related specialty

Skills:
? Comfortable working on teams
Good leadership, written and verbal and communication skills