Pharmacovigilance Risk Management
Alphanumeric Systems, Inc. Warren, NJ
- Expired: over a month ago. Applications are no longer accepted.
In addition, this role will author regulatory documents (e.g. PBRERs, renewal documents, risk management plans, submission documents) according to the agreed process and timelines. Contributes to labelling updates by preparing documentation and presenting to relevant boards. The SERM will participate in project
-focused meetings and provide safety expertise along with safety physician. Contributes to the advancement of methodology and process within safety by generating new ideas and proposals for implementation. As part of a multifunctional project team, this role will contribute to the safety assessment of Innovation and Switch products in the Consumer Health portfolio with intention to bringing new products onto market.
- Contributes to regulatory benefit
-risk assessments, authors Risk Management Plans for designated products for submission to regulatory authorities
- Provides support and input into Clinical Development planning activities, as required
- With guidance, represents SERM on cross
-functional project teams
- Reviews and may provide technical approval for investigator brochures, protocols, informed consents,final study reports and external data monitoring committee charters. Ensures prompt notification to SERM
- Head of any reviewed protocols that are identified as potential PASS
- Ensures that risk
-reduction strategies are implemented appropriately in in relevant documents such asumbrella branding assessments and/or product labelling
Signal Detection, Evaluation and Labeling:
- Performs signal detection for assigned products using available methodologies (e.g. On
-Line SignalmManagement Tool, literature review, individual case awareness tool)
- Uses appropriate sources of information and database searches to retrieve relevant data for evaluationof signals. Analyses safety data and discusses the results with the PV Team Leader / SERM physician and other key stakeholders
- Presents on labeling recommendations to CH Global Labelling Committee and other relevant boards, in partnership with SERM physician
- Produces regulatory supporting documentation for labeling updates
- Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Provides safety input into regulatory requests for local label deviations from the company core data sheet, in partnership with the SERM physician
- Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue; communicates with the SERM physician / PV Team Leader and/or Manufacturing; and documents outcomes
Regulatory Reports and Submissions:
- Authors periodic regulatory documents (PBRERs, DSURs) according to the agreed process and timelines
- Supports the Local Operating Companies by preparing license renewal documentation (e.g. PBRER addenda line listings, clinical overviews, summary bridging reports), as required for each market
- May author the SERM safety contribution to global regulatory submissions for new products, formulations or indications, with strategic guidance from more senior personnel
Other SERM Activities:
- May assist in production of SERM component and/or review of Safety Data Exchange Agreements, and escalates any deficiencies to the PV Team Leader to ensure quality and integrity of agreement
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- May act as a member of a process improvement initiative team within pharmacovigilance function
- Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
We are looking for professionals with these required skills to achieve Company goals:
- Bachelors Degree, or above, in Biomedical or Health Care related specialty.
- 7 + years demonstrated experience with medical and scientific writing.
- Experience in and in
-depth knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
- Experience in and in
-depth understanding of causality assessment, evaluation of safety signals and of proactive risk management strategies, including management of labelling changes, physician and patient education and monitoring of safety issues.
- Experience in other relevant disciplines (e.g. statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug utilization and safety at the population level.
- Experience in medical and drug terminology.
- Understanding of drug development process and the drug approval process in major countries.
- Advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation.
- Agile and distributed decision
-making – using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well
-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action
- a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
Alphanumeric Systems, Inc.
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