Medical Affairs/Safety - Manager, PV Scientist
About The Position
Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests Assists in evaluation and development of Safety Management Plans Assists in data analysis compilation and presentation at cross-functional meetings. Assists in the evaluation of potential safety issues. Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues. Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety. Assists in RMP and DRMP development and updates. Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
Requirements
- Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required.
- A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
- Ability to work in a matrix environment in accordance with the company leadership commitments and values.
- Excellent planning, organization, written and oral communication skills.
- Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements.
- Understanding Signaling tools (e.g., Empirica).
Nice To Haves
- Previous experience in managing drug safety personnel a plus.
- Specific experience in RNA therapeutic area at a global level is an advantage.
- Experience in clinical patient care is a plus.
- Regulatory Inspection readiness experience is a plus.
Responsibilities
- Analyze potential safety issues, including signal detection, signal evaluation and signal management.
- Collaborate proactively with study teams, cross-functional team members, external business partners and vendors.
- Contribute to signaling and data mining activities utilizing internal and external sources of data.
- Perform signaling data review from all sources including Empirica, Clinical and Safety outputs, Literature, and HA requests.
- Assist in evaluation and development of Safety Management Plans.
- Assist in data analysis compilation and presentation at cross-functional meetings.
- Assist in the evaluation of potential safety issues.
- Contribute to activities related to the functioning of safety committees, including preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
- Contribute to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Assist in RMP and DRMP development and updates.
- Support authoring for aggregate safety reports (e.g., PSUR, DSUR, Line listings).
Benefits
- medical
- dental
- vision
- retirement options
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What This Job Offers
Job Type
Full-time
Career Level
Manager
