Senior Manager/ Assistant Director, Pharmacovigilance Agreement Manager
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Role Summary
This position manages and oversees legal contracts between pharmaceutical companies, outlining the responsibilities and procedures for sharing safety data related to drugs, ensuring compliance with regulatory requirements regarding adverse event reporting and risk assessment, while collaborating with legal and drug safety teams to negotiate and maintain these agreements. Responsibilities
Contract drafting and negotiation: Develop and review pharmacovigilance agreements (PVAs) with internal and external stakeholders, including contract terms regarding data exchange, reporting timelines, safety monitoring protocols, and regulatory compliance. Stakeholder management: Collaborate with internal and external stakeholders, including legal teams, drug safety departments, and partner companies, to address PV concerns and maintain effective communication. Ongoing management: Support ongoing management and periodic updating of pharmacovigilance agreements including revising existing agreements or establishing new ones and updating contact lists and appendices. Maintain PVA documentation: Maintain a list of all PVAs in Smartsheet. This includes being Admin for the Smartsheet and performing Admin responsibilities such as back-ups. Maintain accurate records of pharmacovigilance agreements including related documentation. Oversee PV Partner compliance to ensure PVA safety operations obligations are being met by both parties. Qualifications
Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance. Degree / Advanced degree in medicine or in life sciences or equivalent experience e.g. Physician, Pharmacist, Nurse. Excellent communication skills including proficiency in verbal and written English. Proficiency in Microsoft Word and Excel Skills
Pharmacovigilance knowledge: Strong understanding of drug safety principles, adverse event reporting, and risk management practices. Contract experience: Familiarity with legal contracts, terms and conditions, and negotiation strategies. Regulatory awareness: Knowledge of global regulatory requirements related to drug safety reporting. Communication skills: Excellent written and verbal communication to effectively interact with diverse stakeholders. Analytical skills: Ability to analyze complex safety data and assess potential risks associated with drug products.
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This position manages and oversees legal contracts between pharmaceutical companies, outlining the responsibilities and procedures for sharing safety data related to drugs, ensuring compliance with regulatory requirements regarding adverse event reporting and risk assessment, while collaborating with legal and drug safety teams to negotiate and maintain these agreements. Responsibilities
Contract drafting and negotiation: Develop and review pharmacovigilance agreements (PVAs) with internal and external stakeholders, including contract terms regarding data exchange, reporting timelines, safety monitoring protocols, and regulatory compliance. Stakeholder management: Collaborate with internal and external stakeholders, including legal teams, drug safety departments, and partner companies, to address PV concerns and maintain effective communication. Ongoing management: Support ongoing management and periodic updating of pharmacovigilance agreements including revising existing agreements or establishing new ones and updating contact lists and appendices. Maintain PVA documentation: Maintain a list of all PVAs in Smartsheet. This includes being Admin for the Smartsheet and performing Admin responsibilities such as back-ups. Maintain accurate records of pharmacovigilance agreements including related documentation. Oversee PV Partner compliance to ensure PVA safety operations obligations are being met by both parties. Qualifications
Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance. Degree / Advanced degree in medicine or in life sciences or equivalent experience e.g. Physician, Pharmacist, Nurse. Excellent communication skills including proficiency in verbal and written English. Proficiency in Microsoft Word and Excel Skills
Pharmacovigilance knowledge: Strong understanding of drug safety principles, adverse event reporting, and risk management practices. Contract experience: Familiarity with legal contracts, terms and conditions, and negotiation strategies. Regulatory awareness: Knowledge of global regulatory requirements related to drug safety reporting. Communication skills: Excellent written and verbal communication to effectively interact with diverse stakeholders. Analytical skills: Ability to analyze complex safety data and assess potential risks associated with drug products.
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