Job Description

Job Description

Job Description

About the Job

This role reports to the Regional Pharmacovigilance Head – North America. The successful individual will be part of a Global team implementing and maintaining a PV system that is regulatory compliant and will also support the development, registration and commercialization of Glenmark products in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, accurate and timely reporting of adverse events, aggregate safety reports (i.e. PADER) and other Pharmacovigilance activities. This person will assist the LPVRP with tasks including PV related information requests, notifications, health authority inspections, safety restrictions on MAH products marketed in US or Canada, business continuity plans, local PV site file/PSMF, and PV awareness training. The role will also support the medical information function, facilitating in the development of responses and ensuring compliance with the PV and other functions.

Job Responsibilities

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Provide management and leadership support/guidance to the Junior staff on regional regulatory authorities and PV related issues
• Collaborate with the Regional Head and other GPV leadership to set up and maintain an efficient PV system in compliance with national regulations and Glenmark GPV procedures
• Track and report to the Regional Head any regulatory authorities or business changes impacting pharmacovigilance and support the development and implementation of procedures as a result of the changes
• Provide the needed support in the scheduling, compilation, review and timely submissions of Periodic Adverse Drug Experience Reports (PADERS) and other aggregate safety reports to the FDA.
• Request 356h form and relevant PADER contributions from internal stake holders
• Support the creation, maintenance and/or implementation of Glenmark global/regional/local Pharmacovigilance SOPs and Work Instructions
• Responsible for receipt, timely forwarding, follow-up of individual case safety reports ICSRs, quality check of cases as well as monthly reconciliation activities
• Support audit/regulatory inspections and work closely with Regional Head in the implementation and management of CAPAs following the audits/inspections
• Support the development and maintenance of Safety Data Exchange Agreements
• Support the regional Head in maintaining oversight of countries in the America region
• Ensure local personnel are trained in basic pharmacovigilance activities including yearly Pharmacovigilance refresher training
• Serve as a key liaison between the Global Pharmacovigilance, and third party vendors for the management of adverse event reports.
• Support the maintenance and compliance of local PV Site File/trackers
• Have oversight of any local market research programs, non-interventional studies, safety studies and local registries and websites
• Provide relevant information as needed for the compilation of the Pharmacovigilance Master File(PSMF)
• As needed, work with the clinical project teams, attend clinical team meetings and safety review meetings along with medical monitor to ensure consistency in the assessment, recording and coding of clinical safety events (e.g. SAEs).
• Applies Good Clinical Practices in documentation of phone, electronic, and/or fax correspondence regarding initial case reports and follow-ups
• Remain informed of all appropriate current health authority regulations and guidance
• Provide support for the US Point of Contact for handling Medical Information enquiries and associated document development, acting as a point of contact when required
• Perform other duties as assigned by supervisor

Qualifications

Education

• Medical Doctor (MD, DO) preferred or Pharmacist (RPh or PharmD)

Experience

• 3-5 years related experience in a biotechnology or pharmaceutical company or CRO environment
• Minimum of 3 years’ experience in Pharmacovigilance and quality assurance - tactical, operational and strategic capacities is preferred

Knowledge and Skills

• Excellent verbal and written communication skills, proof reading and organization skills
• Comprehensive and working knowledge of Microsoft
• Outlook, Microsoft WORD, Excel and PowerPoint. Electronic document management experience a plus
• Ability to handle sensitive material in a confidential manner
• Strong attention to detail and follow-up skills
• Maintain a high level of diplomacy, discretion, maturity and sound judgement
• Must be flexible and willing to take on significant administrative responsibilities
• Ability to work on multiple tasks simultaneously and balance priorities
• Must handle short deadlines with high level of competency
• Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed
• Must be able to create contingency plans to deal with possible challenges and roadblocks

Physical Demands and Abilities

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office
• Incumbent may encounter frequent interruptions throughout the workday.
• The incumbent is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

Compensation and Benefits

Benefits include:

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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