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Project Manager V
Ref No.: 17-14906
Location: Cambridge, Massachusetts
Major Duties & Responsibilities:
Internal & External Safety Expert:
-Provide PV and risk management expertise to internal and external customers
-Maintain knowledge of product, product environment, and recent literature
-Maintain PV expertise, and understanding of international safety regulations and guidelines
-Lead cross functional Safety Management Teams (SMTs)
-Communicate with and represent PV position within project/product teams, with external partners, and key opinion leaders
-Provide strategic and proactive safety input into development plans
Signal Detection and Assessment:
-Responsible for signal detection and analysis
-Identify and implement proactive safety analysis strategies to further define the safety profile.
-Lead aggregate safety data review activities and coordinate safety surveillance activities
Risk Assessment/Risk Management/ Benefit-Risk Assessment:
-Provide proactive risk assessment
-Co-lead benefit-risk assessment with other relevant functions
Submission Activities:
-Represent safety position in cross functional submission teams
-Ensure generation, consistency, and quality of safety sections in submission documents
-Write responses or contributions to health authorities
-Support preparation of Advisory Committee meetings
Report Writing:
-Document, coordinate, review and validate Periodic reports, e.g.: RMP update, Development Safety Update Report, Periodic Benefit Risk Evaluation Report
-Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.

Major Challenges & Problems:
- Competing priorities and timelines
-Determining the appropriate risk minimization and mitigation measures in light of -B/R assessment in coordination with different parties
-Addressing internal and external customer queries, including those from Health Authorities, in a rapid and effective manner and within appropriate timelines.
The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific
Key Internal/External Relationships:
Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Country Safety Leads
External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring Committees, partners, CROs
Participation in decision making:
-Identify potential signals/issues of pharmacovigilance and evaluate product safety
-Recommend/discuss and coordinate appropriate course of action
-Ask project/product team for necessary amendments, labelling modifications/variations documents as per SOP Information/Decisions to be referred to hierarchy
Basic Qualifications:
M.D. Degree REQUIRED
Minimum 3 years total experience in international pharmacovigilance
Preferred Qualifications:
Board Certified/Board eligible, or equivalent
Excellent clinical judgment
Capability to synthesize and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Demonstrates leadership within cross-functional team environment