Medical Affairs Lead - Pharmacovigilance
Medical Affairs Lead - Pharmacovigilance
Requisition #NAM01045
State/Province New Jersey
City Allendale
Position TypeExempt
This is EdgewellWe are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we re-imagine good mornings and endless summers, beauty and bonding, confidence and determination.
From baby to body, Edgewell is passionate about making the little moments leading up to the big memories just a little bit easier. Simply, we aim to make the products that families rely on more inspired, more personal, and more trustworthy-so they can devote that much more energy to the people they care about most.
We are re-imagining personal care.
At Edgewell Personal Care, we're passionate about helping people be at their best when it matters most:
whether preparing for a first date, practicing for the big game, or protecting your family on vacation. The Edgewell family of brands has a product for everyone -- with well-established brand names such as Schick and Wilkinson Sword men's and women's shaving systems and disposable razors; Edge and Skintimate shave preparations; Playtex , Stayfree , Carefree and o.b. feminine care products; Banana Boat and Hawaiian Tropic sun care products; Playtex infant feeding, Diaper Genie and gloves; and Wet Ones moist wipes.
Position SummaryThis position:
fulfills Company responsibilities in relation to post-market surveillance of product experience including pharmacovigilance. Monitors the safety of commercialized products to detect any change to their risk-benefit balance and to prevent harm from adverse reactions or incidents arising from their use. Ensures serious adverse event processing adheres to regulatory requirements and internal SOPs. The qualified candidate will have experience in and perform multiple activities related to Serious Adverse Event (SAE) case management, data review and document review to satisfy post-market surveillance requirements for drugs, devices and consumer products.
AccountabilitiesReview spontaneous reports of injury or illness to assess severity, causality and/or expectedness against applicable U.S. FDA, U.S. CPSC, Health Canada, Australia CCC and other global regulations for drugs, medical devices and consumer products, including cosmetics.
Based on regional regulatory triggers and definitions, make a decision whether to report SAE's or incidents to appropriate regulatory bodies.
Submit accurate and verifiable data on serious and non-serious adverse reactions, incidents or events to the competent authorities within the legally required time limits.
Prepare and submit CPSC Section 15(b), EU RAPEX and other consumer product potential hazard or product defect reports as needed.
Conduct periodic review of all SAE and incident reports to inform Periodic Safety Update Reports (PSUR), Undesirable Effects Summaries (UES), Risk-Benefit Analyses, Failure Modes and Effects Analyses (FMEAs), Product Safety Clearances and other product risk and safety assessments.
Use periodic safety summaries and scientific knowledge to inform updates to product formulation, design, labeling, intended use and other product features, as needed. Ensure appropriate communication of relevant safety information to consumers.
Review the quality, integrity and completeness of the information submitted on the risks of drugs and medical devices, including processes to avoid duplicate submissions and to validate signals.
Perform signal detection and signal management activities for drugs and medical devices.
Conduct regular reviews of medical and scientific literature and vigilance databases to determine reportability and/or relevance to product safety.
Contribute to the development of risk management plans if needed.
Organize and participate in periodic Safety data review meetings.
Develop SOPs and work instructions related to Drug, Device and Consumer Product Safety / Technovigilance to ensure ongoing compliance with regulations in key markets.
Maintain a high level of understanding of applicable regulations (FDA and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements.
Maintain thorough familiarity with internal SOPs to ensure adherence to internal policy and process requirements.
Interact with other departments (e.g., Regulatory Affairs, Clinical, Product Safety, Quality Assurance, Consumer Affairs and others) to ensure all safety reports are completed and submitted in time and in accordance with internal SOPs and Regulatory reporting timelines.
Manage safety/pharmacovigilance vendors to assure timelines are met, potential issues are communicated and resolution is achieved in a timely manner.
Maintain multiple internal tracking documents related to post-marketing SAE processing.
Required Skills and ExperienceBS/MS or equivalent in a health care field or RN (with clinical experience preferred) or demonstrated equivalent experience necessary to fulfill position requirements.
Knowledge of global regulatory framework for aggregate safety reports is required, including GVP Modules
Minimum 7 years of pharmaceutical or CRO experience, 3 years of which are in a drug safety and pharmacovigilance role. Candidate with less than 7 years of experience will be considered if s/he has an advanced degree in a medical field.
Experience in developing aggregate safety reports (e.g., PBRER/PSUR, CIOMS, UES) is required.
Experience in a clinical research or clinical trial project management role is desirable.
Working knowledge of medical concepts and familiarity with safety activities in drug development and/or post-marketing is required.
Good oral and written communication, organizational skills and personal presentation.
The ability to communicate effectively in English. Ability to write concisely and cogently.
Ability to work independently with little supervision; self-motivation is a must.
Strong sense of urgency and ability to continuously reprioritize.
Ability to manage multiple activities simultaneously.
High degree of attention to detail, organization and timely follow-up.
Excellent interpersonal skills, with ability to interact / communicate effectively across various levels within the organization.
An Offer to Grow OnEdgewell offers a competitive compensation package which includes full medical and retirement savings coverage, paid vacation and holidays. Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.
#LI-DF1
Estimated Salary: $20 to $28 per hour based on qualifications.
Requisition #NAM01045
State/Province New Jersey
City Allendale
Position TypeExempt
This is EdgewellWe are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we re-imagine good mornings and endless summers, beauty and bonding, confidence and determination.
From baby to body, Edgewell is passionate about making the little moments leading up to the big memories just a little bit easier. Simply, we aim to make the products that families rely on more inspired, more personal, and more trustworthy-so they can devote that much more energy to the people they care about most.
We are re-imagining personal care.
At Edgewell Personal Care, we're passionate about helping people be at their best when it matters most:
whether preparing for a first date, practicing for the big game, or protecting your family on vacation. The Edgewell family of brands has a product for everyone -- with well-established brand names such as Schick and Wilkinson Sword men's and women's shaving systems and disposable razors; Edge and Skintimate shave preparations; Playtex , Stayfree , Carefree and o.b. feminine care products; Banana Boat and Hawaiian Tropic sun care products; Playtex infant feeding, Diaper Genie and gloves; and Wet Ones moist wipes.
Position SummaryThis position:
fulfills Company responsibilities in relation to post-market surveillance of product experience including pharmacovigilance. Monitors the safety of commercialized products to detect any change to their risk-benefit balance and to prevent harm from adverse reactions or incidents arising from their use. Ensures serious adverse event processing adheres to regulatory requirements and internal SOPs. The qualified candidate will have experience in and perform multiple activities related to Serious Adverse Event (SAE) case management, data review and document review to satisfy post-market surveillance requirements for drugs, devices and consumer products.
AccountabilitiesReview spontaneous reports of injury or illness to assess severity, causality and/or expectedness against applicable U.S. FDA, U.S. CPSC, Health Canada, Australia CCC and other global regulations for drugs, medical devices and consumer products, including cosmetics.
Based on regional regulatory triggers and definitions, make a decision whether to report SAE's or incidents to appropriate regulatory bodies.
Submit accurate and verifiable data on serious and non-serious adverse reactions, incidents or events to the competent authorities within the legally required time limits.
Prepare and submit CPSC Section 15(b), EU RAPEX and other consumer product potential hazard or product defect reports as needed.
Conduct periodic review of all SAE and incident reports to inform Periodic Safety Update Reports (PSUR), Undesirable Effects Summaries (UES), Risk-Benefit Analyses, Failure Modes and Effects Analyses (FMEAs), Product Safety Clearances and other product risk and safety assessments.
Use periodic safety summaries and scientific knowledge to inform updates to product formulation, design, labeling, intended use and other product features, as needed. Ensure appropriate communication of relevant safety information to consumers.
Review the quality, integrity and completeness of the information submitted on the risks of drugs and medical devices, including processes to avoid duplicate submissions and to validate signals.
Perform signal detection and signal management activities for drugs and medical devices.
Conduct regular reviews of medical and scientific literature and vigilance databases to determine reportability and/or relevance to product safety.
Contribute to the development of risk management plans if needed.
Organize and participate in periodic Safety data review meetings.
Develop SOPs and work instructions related to Drug, Device and Consumer Product Safety / Technovigilance to ensure ongoing compliance with regulations in key markets.
Maintain a high level of understanding of applicable regulations (FDA and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements.
Maintain thorough familiarity with internal SOPs to ensure adherence to internal policy and process requirements.
Interact with other departments (e.g., Regulatory Affairs, Clinical, Product Safety, Quality Assurance, Consumer Affairs and others) to ensure all safety reports are completed and submitted in time and in accordance with internal SOPs and Regulatory reporting timelines.
Manage safety/pharmacovigilance vendors to assure timelines are met, potential issues are communicated and resolution is achieved in a timely manner.
Maintain multiple internal tracking documents related to post-marketing SAE processing.
Required Skills and ExperienceBS/MS or equivalent in a health care field or RN (with clinical experience preferred) or demonstrated equivalent experience necessary to fulfill position requirements.
Knowledge of global regulatory framework for aggregate safety reports is required, including GVP Modules
Minimum 7 years of pharmaceutical or CRO experience, 3 years of which are in a drug safety and pharmacovigilance role. Candidate with less than 7 years of experience will be considered if s/he has an advanced degree in a medical field.
Experience in developing aggregate safety reports (e.g., PBRER/PSUR, CIOMS, UES) is required.
Experience in a clinical research or clinical trial project management role is desirable.
Working knowledge of medical concepts and familiarity with safety activities in drug development and/or post-marketing is required.
Good oral and written communication, organizational skills and personal presentation.
The ability to communicate effectively in English. Ability to write concisely and cogently.
Ability to work independently with little supervision; self-motivation is a must.
Strong sense of urgency and ability to continuously reprioritize.
Ability to manage multiple activities simultaneously.
High degree of attention to detail, organization and timely follow-up.
Excellent interpersonal skills, with ability to interact / communicate effectively across various levels within the organization.
An Offer to Grow OnEdgewell offers a competitive compensation package which includes full medical and retirement savings coverage, paid vacation and holidays. Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.
#LI-DF1
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
