Associate Director, Drug Safety

About the role

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 pharmacovigivalence perspective. He / She will communicate relevant information internally and with other members of SUN and its affiliates, including stakeholders as required.

Responsibilities

• 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
• 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

Pay

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.

Benefits

• Health & Wellness: Comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
• Financial: Competitive 401(k) match program and financial wellness programs to support short- and long-term financial goals.
• Life, Work & Family: Work-life benefits that support beyond the workday.

About Us

Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.

Our Values

Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.