Director, Safety Physician, Global Pharmacovigilance
Found in: Lensa US P 2 C2 - 2 weeks ago
Our client's vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection.
The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician assists in the successful development, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This individual will provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and postmarketing surveillance. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Job Responsibilities
Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
Responsible for the review and communication of safety data trending, signalling and other safety related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process.
Responsible for the development of review/response documents for safety issues arising from internal review or regulator feedback.
Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues
Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
Author medical-safety sections of aggregate safety reports (DSUR, PBRER)
Participate in development of safety-related responses to queries from Regulatory Authorities
Maintain knowledge of disease and therapeutic areas for marketed products and products in development
Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.).
Job Requirements
M.D./D.O Degree
Experience in Pharmacovigilance, particularly with individual case review and evaluation.
Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
Knowledge of clinical development process
Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
Experience with commercially available safety databases.
At least three years of practical clinical experience post licensure
At least three years of pharmacovigilance experience
Knowledge of drug approval process in major countries.
#J-18808-Ljbffr
-
Senior Director, PV Medical Surveillance
3 days ago
Philadelphia, United States CareerBuilder Full timeSenior Director, PV Medical Surveillance About the Company International medical surveillance organization Industry Security and Investigations Type Privately Held About the Role The Senior Director, PV Medical Surveillance will be responsible for providing medical expertise to assigned project teams, overseeing the identification and investigation of safety...
-
Environment Health Safety Specialist
1 week ago
Philadelphia, United States Global Channel Management Full timeAbout the job Environment Health Safety Specialist Environment Health Safety Specialist needs 10 years experience with at least 5 in a management role and corporate experience Environment Health Safety Specialist requires: B.Sc. degree in safety management, engineering, or related field. Track record of creating increased awareness, heightened standards,...
-
Director, Global Strategic Insights
Found in: beBee jobs US - 41 minutes ago
Philadelphia, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: UK - London - Brentford, USA - Pennsylvania - PhiladelphiaPosted Date: Apr We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one...
-
Medical Director, Principal Investigator, Lead Physician
Found in: Jooble US O C2 - 2 weeks ago
Philadelphia, PA, United States Chapel Hill Solutions Full timeMedical Director, Principal Investigator, Lead Physician Philadelphia, PA We are currently seeking a talented and dedicated Medical Director, Principal Investigator, or Lead Physician for a great opportunity in the Philadelphia, PA area. The ideal candidate will possess 1 year of current experience working in a clinical research organization and have 5+...
-
Director of Technical Operations
2 weeks ago
Philadelphia, United States Global Life Science Hub Full timeJob DescriptionJob DescriptionGlobal Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be...
-
Director, Quality Operations
1 week ago
Philadelphia, United States Global Life Science Hub Full timeJob DescriptionJob DescriptionGlobal Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be...
-
Director, HR Business Partner
1 week ago
Philadelphia, United States Axalta Full timeJob Description: The Director, HR Business Partner - Global Technology will work in partnership with key executive and senior leaders on a global scale in the development and delivery of people strategies and plans to build a talented, sustainable team of Axalta colleagues. In this role, you will develop relationships with peers, business stakeholders and...
-
Director of Distribution
Found in: Appcast US C2 - 3 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Director of Distribution oversees the...
-
Director of Distribution
Found in: Appcast Linkedin GBL C2 - 3 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Director of Distribution oversees the...
-
Director of Distribution
2 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Director of Distribution oversees the...
-
Director of Technical Operations
Found in: Resume Library US A2 - 1 week ago
Philadelphia, Pennsylvania, United States Global Life Science Hub Full timeGlobal Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be leading a search for a brand-new...
-
Director, Quality Operations
Found in: Resume Library US A2 - 1 week ago
Philadelphia, Pennsylvania, United States Global Life Science Hub Full timeGlobal Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be leading a search for a brand-new...
-
Director of Distribution
Found in: Appcast US C2 - 6 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Warehouse Manager oversees the productivity and...
-
Director of Distribution
6 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Warehouse Manager oversees the productivity and...
-
Director of Distribution
Found in: Appcast Linkedin GBL C2 - 5 days ago
Philadelphia, United States DSJ Global Full timeThe Director of Distribution is responsible for the efficient and safe operation of the warehouse, including the receipt, storage, retrieval and dispatch of goods. Ensures compliance with health and safety standards, security of the building and stock, and optimal arrangement of goods within the warehouse. The Warehouse Manager oversees the productivity and...
-
Medical Director, Principal Investigator, Lead Physician
Found in: Jooble US O C2 - 2 weeks ago
Philadelphia, PA, United States Chapel Hill Solutions Full timeMedical Director, Principal Investigator, Lead Physician We are currently seeking a talented and dedicated Medical Director, Principal Investigator, or Lead Physician for a great opportunity in the Philadelphia, PA area. The ideal candidate will possess 1 year of current experience working in a clinical research organization and have 5+ years of experience...
-
Medical Director
4 days ago
Philadelphia, United States Independence Blue Cross Full timeAt Independence, everyone can feel valued, supported, and comfortable to be themselves. Our commitment to equity means that all associates have a fair opportunity to achieve their full potential. We put these principles into action every day by acting with integrity and respect. We stand together to speak out against injustice and to break down barriers to...
-
Medical Director
1 week ago
Philadelphia, United States Independence Blue Cross Full timeAt Independence, everyone can feel valued, supported, and comfortable to be themselves. Our commitment to equity means that all associates have a fair opportunity to achieve their full potential. We put these principles into action every day by acting with integrity and respect. We stand together to speak out against injustice and to break down barriers to...
-
Medical Director
3 days ago
Philadelphia, United States Independence Blue Cross Full timeAt Independence, everyone can feel valued, supported, and comfortable to be themselves. Our commitment to equity means that all associates have a fair opportunity to achieve their full potential. We put these principles into action every day by acting with integrity and respect. We stand together to speak out against injustice and to break down barriers to...
-
Director of Finance and Analytics
Found in: Appcast Linkedin GBL C2 - 5 days ago
Philadelphia, United States Alpine Solutions Group Full timeMUST:5+ of revenue cycle healthcare experience5+ years of finance and analytics within healthcare (we need rev cycle, patient accounting/insurance billing, and good with data) 2+ years experience in healthcare finance leadership/supervisory role Experience doing data analysis with AR, charge posting, payment posting, payor trends. Knowledge of Debits,...
