Title:  Associate Director, Drug Safety

The Associate Director, Drug Safety (Title commensurate to the overall experience) will oversee and implement operations of Pharmacovigilance in North America and will ensure overall compliance of North America business of SUN and its affiliates from pharmacovigilance perspective.  He /She will communicate relevant information internally and with other members of SUN and its affiliates, including stakeholders as required.  The Associate Director will be responsible for ensuring ADE training and/or communication of handling ADEs for non-Drug Safety personnel and review of market research surveys received from a pharmacovigilance perspective.

The position will lead teams based out of USA, Canada & will liaise with pharmacovigilance teams based in other geographical locations. 

Responsibilities include the following:

FDA, Health Canada and Internal Audit Inspections:

• Ensure audit preparedness and manage regulatory and internal inspections
• Draft any corrective action/preventative action plans (CAPA) as necessary

Compliance Monitoring:

• Ensure compliance to PV SOPs implemented in North America and generate the regional monthly PV report
• Provide root cause analysis (RCA) and CAPA for North America late reporting as applicable
• Ensure procedural deviations are appropriately documented.
• Oversee subset of quality review/quality management of Individual Case Safety Reports (CSRs)

Medical Inquiry (MI) Management:

• Ensure MIs are addressed in a timely manner as per internal procedures and address and support responses to MIs as needed

Exchange of Safety Information with Business Partners:

• Manage drafting, execution and maintenance of Safety Data Exchange Agreements (SDEAs)
• Negotiate SDEAs with BPs
• Review QA agreements and business contracts and review of PV obligations as per the SDEAs
• Ongoing compliance to SDEAs

SOPs training

• Develop Drug Safety Standard Operating Procedures and ensure training for Drug Safety personnel

Adverse Drug Experiences (ADEs) in North America

• ADE management per applicable procedures
• Ensure ADEs are forwarded to GPV for processing and ensure follow ups for ADEs are performed as applicable

Periodic reports

• Ensure review of periodic reports at US Drug Safety prior to submission to the FDA and approve periodic reports prior to submission
•    Ensure review of Canada PSURs occurs by the Canada Drug Safety RPP or designee prior to PSUR finalization

Risk Management

•   Manage and support Risk Management programs including review of associated documents and ensure compliance to the programs, as applicable. Participate in the development, implementation and maintenance of Risk Management programs and make decisions on behalf of Sun Pharma and Taro Pharma. Liaise with internal and external stakeholders, as required.

Budgets

• Management of budgets of PV operations.

PV support to clinical development programs of North America

• Providing required inputs and PV support to clinical development programs in North America

Committees & Stakeholder Management

• Being part of drug safety committees and cross functional committees representing drug safety
• Establish a proactive approach to enhance and preserve satisfaction amongst consumers, healthcare professionals, customers, and all stakeholders, both internal and external
• Utilize and enhance the IT tools at hand to help enhance the efficiency of PV operations

Qualifications:

• PharmD, Master’s in Pharmaceutical Sciences or MD required
• 10-12 years’ experience in Pharmacovigilance or related field
• Supervisory experience required

The presently-anticipated base compensation pay range for this position is $162,000 to $180,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.