Atlas Venture
Associate Director, Pharmacovigilance Scientist
Atlas Venture, Waltham, Massachusetts, United States, 02254
Associate Director, Pharmacovigilance Scientist
Company Address:
890 Winter Street Suite 220, Waltham, MA 02451
About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical‑stage injectable and oral therapies for the treatment of obesity and related conditions.
Job Description At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team‑oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You Will Do:
The Associate Director, Pharmacovigilance Scientist will provide leadership, guidance, and support to signal management, benefit‑risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle with focus on patients’ well‑being and compliance with applicable regulatory requirements. They will collaborate cross‑functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.
Required location: Waltham, MA (onsite or hybrid 2‑3 days per week).
Responsibilities
Perform and coordinate benefit‑risk assessment and safety surveillance activities
Support the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross‑functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad‑hoc safety reviews
Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross‑functionally to access and utilize data visualization and analysis tools for regular and ad‑hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)
Contribute to responses to drug safety related health authority requests
Provide input into the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed
Contribute to the preparation of the safety sections of regulatory submission modules
Represent DSPV on audits/inspections and contribute to safety responses as needed
Contribute to responses to deviations and CAPAs related to pharmacovigilance
Lead and actively contribute to the preparation and implementation of procedural documents as applicable to pharmacovigilance
Contribute as needed to the Global DSPV Business Continuity Plan
Provide content for pharmacovigilance training as needed
Contribute to the implementation of innovative technical or procedural solutions to improve DSPV safety surveillance capabilities
Other responsibilities as assigned
Required Qualifications
A minimum of 5‑7 years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO settings
Experience in safety data analysis, signal management, and benefit‑risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly
Preferred Qualifications
Prior experience contributing to clinical study or regulatory submission documents
Knowledge of drug/biologics development process
Experience with health authority pharmacovigilance inspections
Education
Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, healthcare or other related life sciences field is required. MD or Ph.D. degree is a plus
Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well‑being and financial security of our team members and their families.
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance
Salary Range $160,000‑$200,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
At Kailera, we are committed to fostering an inclusive culture. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
#J-18808-Ljbffr
890 Winter Street Suite 220, Waltham, MA 02451
About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical‑stage injectable and oral therapies for the treatment of obesity and related conditions.
Job Description At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team‑oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You Will Do:
The Associate Director, Pharmacovigilance Scientist will provide leadership, guidance, and support to signal management, benefit‑risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle with focus on patients’ well‑being and compliance with applicable regulatory requirements. They will collaborate cross‑functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.
Required location: Waltham, MA (onsite or hybrid 2‑3 days per week).
Responsibilities
Perform and coordinate benefit‑risk assessment and safety surveillance activities
Support the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross‑functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad‑hoc safety reviews
Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross‑functionally to access and utilize data visualization and analysis tools for regular and ad‑hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)
Contribute to responses to drug safety related health authority requests
Provide input into the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed
Contribute to the preparation of the safety sections of regulatory submission modules
Represent DSPV on audits/inspections and contribute to safety responses as needed
Contribute to responses to deviations and CAPAs related to pharmacovigilance
Lead and actively contribute to the preparation and implementation of procedural documents as applicable to pharmacovigilance
Contribute as needed to the Global DSPV Business Continuity Plan
Provide content for pharmacovigilance training as needed
Contribute to the implementation of innovative technical or procedural solutions to improve DSPV safety surveillance capabilities
Other responsibilities as assigned
Required Qualifications
A minimum of 5‑7 years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO settings
Experience in safety data analysis, signal management, and benefit‑risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly
Preferred Qualifications
Prior experience contributing to clinical study or regulatory submission documents
Knowledge of drug/biologics development process
Experience with health authority pharmacovigilance inspections
Education
Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, healthcare or other related life sciences field is required. MD or Ph.D. degree is a plus
Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well‑being and financial security of our team members and their families.
Comprehensive health benefits and tax‑advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year‑end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance
Salary Range $160,000‑$200,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
At Kailera, we are committed to fostering an inclusive culture. We share the pay range for this particular role with the actual base salary depending upon factors such as job‑related knowledge, skills, market factors, and experience.
E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
#J-18808-Ljbffr