Safety Physician Job
Company Name:
Arca24.com
Salary period: Annual
Safety Physician needed for a contract opportunity with Yoh's client located in Collegeville, PA area.
What You'll Be Doing:
- Provides high level medical expertise in the safety evaluation and risk management of key assets or other highly complex products in clinical development and/or the post-marketing setting
- Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labeling updates and drive proactive implementation of risk management initiatives
- Provides global leadership of safety evaluation and risk management activities throughout the product's entire life cycle and shows confidence, credibility and influence at all levels of the organization and possibly, externally
- Presents the disease area or product area safety strategy at key internal meetings, and fully represents externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
- Accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs)
- May deputies for the TA Director
- May participate in, or lead activities such as safety advisory panels, interfaces with high levels outside GCSP on a regular basis and may be recognized as a key player in external international Pharmacovigilance activities
- Leads thinking in GCSP around risk management plans and their implementation.
- For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical Matrix and leads production of Global Benefit-Risk Management Plans Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Delivers the clinical safety input into clinical development planning activities
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- Presents safety information at clinical investigator and commercial meetings.
- Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS GCSP representative on cross functional clinical Matrix teams and/or project teams.
- Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labeling, as appropriate Provides medical expertise for risk evaluation and risk management planning
- Signal Detection, Evaluation and Labeling
What You Need to Bring to the Table:
- Medical Degree Expert evaluation skills and analytical thinking
- Outstanding medical writing skills
- Sound computing skills
- Expert knowledge of relevant Pharmacovigilance regulations and methodologies applicable to SERM activities
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labeling changes, physician and patient education.
- Likely to be recognized as an authority in this area at high levels within outside of GCSP and also possibly in the external international Pharmacovigilance arena
- In depth knowledge of the therapeutic area of assigned products In depth knowledge of other related disciplines, eg statistics, epidemiology relevant to assessing drug utilization and safety at the population level In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
Opportunity is Calling, Apply Now!
Recruiter: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: HC
MONJOB
J2WMIDATL
Ref:
SFSF: LSEstimated Salary: $20 to $28 per hour based on qualifications.
Arca24.com
Salary period: Annual
Safety Physician needed for a contract opportunity with Yoh's client located in Collegeville, PA area.
What You'll Be Doing:
- Provides high level medical expertise in the safety evaluation and risk management of key assets or other highly complex products in clinical development and/or the post-marketing setting
- Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labeling updates and drive proactive implementation of risk management initiatives
- Provides global leadership of safety evaluation and risk management activities throughout the product's entire life cycle and shows confidence, credibility and influence at all levels of the organization and possibly, externally
- Presents the disease area or product area safety strategy at key internal meetings, and fully represents externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
- Accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs)
- May deputies for the TA Director
- May participate in, or lead activities such as safety advisory panels, interfaces with high levels outside GCSP on a regular basis and may be recognized as a key player in external international Pharmacovigilance activities
- Leads thinking in GCSP around risk management plans and their implementation.
- For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical Matrix and leads production of Global Benefit-Risk Management Plans Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Delivers the clinical safety input into clinical development planning activities
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- Presents safety information at clinical investigator and commercial meetings.
- Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS GCSP representative on cross functional clinical Matrix teams and/or project teams.
- Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labeling, as appropriate Provides medical expertise for risk evaluation and risk management planning
- Signal Detection, Evaluation and Labeling
What You Need to Bring to the Table:
- Medical Degree Expert evaluation skills and analytical thinking
- Outstanding medical writing skills
- Sound computing skills
- Expert knowledge of relevant Pharmacovigilance regulations and methodologies applicable to SERM activities
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labeling changes, physician and patient education.
- Likely to be recognized as an authority in this area at high levels within outside of GCSP and also possibly in the external international Pharmacovigilance arena
- In depth knowledge of the therapeutic area of assigned products In depth knowledge of other related disciplines, eg statistics, epidemiology relevant to assessing drug utilization and safety at the population level In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
Opportunity is Calling, Apply Now!
Recruiter: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: HC
MONJOB
J2WMIDATL
Ref:
SFSF: LSEstimated Salary: $20 to $28 per hour based on qualifications.
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