JOB DESCRIPTION:
Primary Job Function:
The primary function of the Manager Risk Management is to provide leadership, oversight, and support for preparation and maintenance of Risk Management Plans,
This includes
- Central contact point for Risk Management Plans across all global products
- Proactive screening of risk management legislation / guidelines and subsequent implementation into standard operating procedures and templates covering preparation and maintenance of risk management plans.
- Accountability, timely planning and preparation of Risk Management plans
Core Job Responsibilities:
- Provides guidance and expertise for all functions involved in Risk Management Plan preparation (e.g. Medical Affairs, Regulatory Affairs, Clinical Development and Product Safety Teams) and ensures interdisciplinary alignment.
- Proactively understands regulatory framework, trends and requirements related to Pharmacovigilance, clinical studies and global drug development
- Provides advice across functions for risk categorization and characterization.
- Performs Gap analysis of risk management legislation/guidelines and regulatory framework with trends and requirements versus content in standard operating procedures and supporting documents concerning risk management plan preparation and maintenance.
- Intelligence for rapidly changing needs in RMP regulations, Biosimilars regulations and additional risk Minimization Measures.
- Independently analyze pharmacovigilance safety data and produce scientifically sound summaries and reports.
- Ensures in cooperation with Regulatory Affairs close alignment of regulatory strategies and Risk Management Plan updates, and thereby, participates in the identification, direction, and implementation of strategic business initiatives.
- Expert in latest EU GVP Module V Rev 2 format and content requirements, EU GVP, MX, BR guidance, global RMP strategies. Expert in RMP requirements for emerging markets, document requirements and localizations and adaptations (e.g. Colombia, Russia, Brazil, Peru).
- Knowledge with additional risk Minimization Measures tracking and effectiveness check.
- Ensures response to deficiency letters from regulatory authorities is provided in time.
- Supports affiliates in regard to Risk Management Plan preparation and maintenance for local products.
- Point of contact for training activities and development of training materials in regard to risk management plan.
- Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions toxicity, and medication errors during periodic report preparation. This includes the consideration if safety data quality as a new safety signal or as a new identified or potential risk or may potentially alter any previous signal or risk assessment.
- Management of Vendors involved in medical writing activities (RMPs, periodic reports).
Supervisory/Management Responsibilities:
Direct Reports: 0
Indirect Reports: 0
Position Accountability/Scope:
- Is accountable for Abbott's procedure which should be in line with the global and local requirements
- Works mostly independent but will require some oversight/guidance.
Minimum Education:
- Master of Pharmacy or comparable master's degree in health sciences, Ph.D.
Minimum Experience/Training Required:
- Minimum 8 years industry experience in Pharmacovigilance and 5 years in RMP preparation according to EU GVP Module V format.
- Broad and proficient understanding of RMP regulations in EU and LATAM and other emerging countries markets. Robust understanding of medical conditions and disease state entities, able to critically evaluate pharmaceutical/medical data.
- Experienced professional operating within the international arena and working across functional areas.
- Good negotiating skills, tact, and diplomacy. Advanced knowledge of standard business procedure, very good project management skills, proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g., ISI writer).
- Very good communication and presentation skills (oral and in writing) in English.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical Writing
DIVISION:
EPD Established Pharma
LOCATION:
India Mumbai : Mumbai Development Center - EPD
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
